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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SURESCAN SPINAL CORD STIMULATOR

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MEDTRONIC SURESCAN SPINAL CORD STIMULATOR Back to Search Results
Model Number 97714
Device Problems Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); Low Battery (2584)
Patient Problems Fall (1848); Headache (1880); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Numbness (2415); Electric Shock (2554)
Event Date 12/27/2013
Event Type  Injury  
Event Description
Reporter complaining that the electronic stimulation device placed in his back has damaged his nerves and given him an infection at the site from fluid build up. Device implanted by dr. (b)(6) in (b)(6), and has never worked correctly since implantation. Receiving shocks that were painful and the medtronic rep attempted to adjust the device; however, the shocks continued so the dr turned the device off. The battery life ran out too quickly. Receive jolts whenever he moved to quickly that went down his leg and up his spine. Also had migraines from the device. Dr had an attitude when he complained and turned the device off, said he could not remove it because he was going on vacation. His associate removed the device. Once the device was removed, the headaches stopped. Headaches were so bad that he thought he had meningitis. Has been told that he has nerve damage from the fluid build up and the wires in his spine. Now complains of numbness in legs and falling when trying to walk. Fell recently and has torn rotator cuff and the meniscus in his knees may also be torn. Lot numbers 2 lead kits (va0d0hg008 and va0d0hg007), lead wire (977a160), charging system (nku106862n), and pt programmer (nmh019498n). Ref # 3004209178-2016-18570, 3004209178-2016-18572.
 
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Brand NameSURESCAN SPINAL CORD STIMULATOR
Type of DeviceSPINAL CORD STIMULATOR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6085084
MDR Text Key59522517
Report NumberMW5065852
Device Sequence Number1
Product Code LGW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number97714
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/07/2016 Patient Sequence Number: 1
Treatment
DIAZEPAM; GABAPENTIN; HYDROCODONE
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