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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 Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Discomfort (2330); Electric Shock (2554)
Event Date 05/26/2021
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 (pt) regarding an implantable neurostimulator (ins). The reason for call was the pt was implanted yesterday and when the pt got home yesterday they stood up and got a stabbing feeling in the hip which was uncomfortable for them. Pt said in certain ways that they move or turn they get shocked all the way down the leg to the toes on the left side. Pt said they had to shut it off (it was understood they shut their ins off). Pt said that they should not have allowed themselves to get implanted for it was not a good thing for them. Pt mentioned that they had rods in their back and they cant turn or sit the wrong way. Pt said they were in a lot of pain. The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key11903112
MDR Text Key263107200
Report Number2182207-2021-00932
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received06/08/2021
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

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