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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Battery Problem (2885); Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from the consumer via the manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that there were discharges. The device discharged six times a day. Factors that may have led or contributed to the issue was no event. Troubleshooting included checking impedances which were okay, changing programs, stopping the adaptive stimulation, and stopping stimulation where there were no more discharge. An appointment was scheduled with the doctor on (b)(6) 2020. The issue was not resolved. The patient stopped the ins and would use an external neurostimulator until the scheduled appointment. The patient was alive with injury. Additional information was received reporting that the lead was tested in the operating room, the patient can¿t use the internal stimulation anymore. The patient uses external stimulation. No action or change was planned.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10804523
MDR Text Key216664787
Report Number2182207-2020-01234
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 11/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/06/2020 Patient Sequence Number: 1
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