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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paralysis (1997)
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¿s family member regarding a patient with an implantable neurostimulator (ins) via a manufacturer representative (rep). It was reported that after ins implant surgery, the patient had no effect at all. ¿the hands could be moved before the surgery, but the hands could not be moved after the surgery. The doctor advised the patient to explant the ins. The device was working normally. No further patient complications were reported as a result of this event.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12610747
MDR Text Key275876156
Report Number2182207-2021-01773
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
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: 10/11/2021 Patient Sequence Number: 1
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