Medtronic declares that this product is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices and R&TTE Directive 1999/5/EC. The recharger should remain connected to the AC power supply until the recharging session has finished. Unfortunately,spinal-cord stimulator implant recalls are far from rare. May 2016. Roughly half the recalls involved stimulators made by Medtronic, the world’s largest device manufacturer, though none warned of a risk of serious injury or death. To prevent this error, the recharger should be plugged into the AC power supply (by aligning the white triangles) prior to starting a recharging session of your neurostimulator. The letter described the problem and the product involved in the recall. It is the recalled model 97714. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Instructions for Downloading Viewers and Players. The MRI SureScan™ feature permits a mode of operation that allows a patient with a SureScan device to be safely scanned by an MRI machine. The recall is a "class I" recall, which the FDA says is "the most serious type of recall." The Medtronic RestoreSensor® Model 37714 and RestoreSensor® SureScan® (MRI) Model 97714 Neurostimulators are part of a neurostimulation system for pain therapy. Refer to the list of Medtronic contacts at the end of this manual. 97714 2016-06-01 English 11 Medtronic Neuromodulation - RestoreSensor and RestoreSensor SureScan - Class 2 Recall Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual. In fact, manufacturers issued more than 50 such recalls since 2005. The recall affects A. MiniMed 670G System Support > Find Your Serial Number Find Your Serial Number Device: MiniMedTM 670G insulin pump (MMT-1780K) You may need your pump serial number if you call 24-Hour Technical Support. Whether your child was just diagnosed with diabetes or has been managing it for some time, Medtronic is the right place to turn for help. Over 250,000 families with a family member with diabetes count on Medtronic and our diabetes products. Medtronic. CDRH maintains searchable databases on its website containing 510(k) and PMA information. I had a medtronics stim implanted in 2016. Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. I had a medtronic pain stimulator model number 97714 implanted in march 2017. Description: This physician communication provides important information regarding reports of rapid battery depletion when a charging session was terminated prior to reaching sufficient battery voltage. Recall Status 1: Terminated 3 on November 07, 2014: Recall Number: Z-1524-2014: Recall Event ID: 66841: PMA Number: P840001 : Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW: Product: Medtronic neurostimulators. The stimulation settings are stored in programs. If you have a spinal cord stimulation device implanted and have any questions or concerns regarding this issue, contact your managing health professional. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Stimulator, spinal-cord, totally implanted for pain relief, Code of Federal Regulations (CFR) Title 21 §7.55, PMAs with Product Code = LGW and Original Applicant = MEDTRONIC NEUROMODULATION, Instructions for Downloading Viewers and Players, Class 2 Device Recall RestoreSensor and RestoreSensor SureScan. The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use i... Medtronic, External neurostimulator, ENS (37021) & ENS (37022). As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Medtronic asserts that the Act was also intended, however, to-protect innovations in device technology from being `stifled by unnecessary restrictions,' " Brief for Petitioners in No. Instructions for Downloading Viewers and Players. This tool will provide results only for current CRHF implantable IPG, ICD and CRT devices and leads. The letter was addressed to "Healthcare Professional". Medtronic Neuromodulation Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable N... 2 06/07/2016 Medtronic Neuromodulation Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English. I had a major malfunction in 2019. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Consignees were sent on 5/3/2016 a Medtronic "Urgent Medical Device Safety notification" letter dated May 2016. Another company, St, Jude Medical, had taken some legal heat from its Eon Mini Spinal Stimulator product. Recall Status 1: Terminated 3 on August 04, 2017: Recall Number: Z-1926-2016: Recall Event ID: 74059: PMA Number: P840001 : Product Classification: Stimulator, … Medtronic Neuromodulation - SynchroMed II Implantable Infusion Pump - Class 1 Recall Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) View the components of the SureScan MRI system used for spinal cord stimulation, including implantable neurostimulators, leads, and anchors. Medtronic is the world’s largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill the Mission of alleviating pain, restoring health, and extending life. There are three places to find the serial number of your insulin pump: On the back of your pump On the status screen on your pump In your Diabetes.Shop account 1. Spinal cord stimulation leads. AccessGUDID - RestoreSensor™SureScan® (00643169109483)- INS 97714 RESTORE SENSOR MRICS (Source: Medical Device Recalls) A total of 11,299 SynchroMedTM II pumps manufactured from May 2018 to April 2019 could be potentially affected by the presence of a … Problems associated with this issue are rare and removal of implanted devices in the absence of symptoms is not recommended. Phone 2018 - Medtronic Spinal Stimulator Pain. According to the complaint, originally filed by former Medtronic sales rep Jason Nickell, Medtronic sales staff were directed to sell the device at discounted prices to pain management doctors. For further information as well as details concerning the device please see the enclosed Advisory Notice of the manufacturer. All lot/serial numbers are affected for both Model numbers 37714 and 97714. The neurostimulators are multi-programmable, rechargeable devices that deliver stimulation through 1 or more leads. Medtronic declares that this product is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices. Note: If you need help accessing information in different file formats, see