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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number NEU_ENS_STIMULATOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Insufficient Information (4580)
Event Date 07/29/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from a patient regarding a wireless external neurostimulator (wens). It was reported that patient called in for assistance with her trial device as she's not sure what to do with the device and if it's working and she is experiencing pain. The reason for call was trial pt mentioned they had intense pain in left thigh since implant date. Healthcare provider (hcp) mentioned pain might be related to some nerve damage caused from implant surgery and "cutting out part of the spine" to get leads into epidural space. Trial pt mentioned pain had been improving; trail pt could not touch left leg after surgery and now trial pt can touch left leg. Trial pt also mentioned the therapy for pain in knees seemed to be working; prior to spinal cord stimulator, intense pain in knees used to wake trial pt up at night, but now, the trial pt said they did not wake up from pain in knees at night. The patient was redirected to their healthcare provider to further address the issue. Trial pt had not spoken to manufacturing representative (rep) about pain in left thigh; patient services specialist also suggested trial pt contact rep. Trial pt was implanted on (b)(6) 2021.

 
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Brand NameEXTERNAL NEUROSTIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12277979
MDR Text Key265158141
Report Number2182207-2021-01355
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_ENS_STIMULATOR
Device Catalogue NumberNEU_ENS_STIMULATOR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2021
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: 08/04/2021 Patient Sequence Number: 1
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