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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97716
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Electric Shock (2554)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that there was pain in the pocket. The patient got an electrical shock kind of feeling to the ins pocket when he bent forward. It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. All programs were turned to zero, the device was turned off, and impedance was checked. The patient has had the ins shut off for a long time and got this always when bending forward. The issue occurred during normal use. The issue was not resolved as of 18-aug-2021. A session report was provided that showed all impedance values within normal limits. A device data report was also provided.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12345047
MDR Text Key267357788
Report Number3004209178-2021-12673
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeFI
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/14/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2021
Device MODEL Number97716
Device Catalogue Number97716
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/07/2020
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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