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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problems Failure to Deliver Energy (1211); Data Problem (3196)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 07/05/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from a patient regarding their implantable neurostimulator (ins). Information was reported that the patient reported yesterday he was trying to charge his ins and the language changed. The patient was provided instructions on changing the language back to english. The patient stated he was set to group b before the language changed, but now the controller indicated group a was active, and he does not feel stimulation. The patient confirmed that stimulation was on. The patient was provided instructions on how to change the stimulation back to group b. The patient confirmed that he now felt stimulation. No further complications were reported. No additional patient symptoms were reported.

 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
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 Key10241817
MDR Text Key199534117
Report Number2182207-2020-00489
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
Report Date 07/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_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 Received07/06/2020
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

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