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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 Name
SURESCAN
Type of Device
STIMULATOR, 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 Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 10/28/2020
Initial Date FDA Received11/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age38 YR
Patient Weight90
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