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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
Patient Problems Incontinence (1928); 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 (rep), healthcare provider (hcp)) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that patient states the stimulator doesn't work, that he is getting shocks (but can't remember if it happens all the time, when it's on or off etc) he also complains that he feels that he is going to "pee himself" but again couldn't verbalize if this happens with the dev on/off. He also stated he hasn't used it since it was implanted, then said he used it on and off since last week.  the factors related to this are unknown however the patient had failed to return phone calls in the past and never reported issues with the device until now. The rep will be meeting with the patient to check the ins status. No interventions planned at this time it is likely they patient will be referred back to his neurosurgeon. The issue has not been resolved at this time.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11123948
MDR Text Key225749274
Report Number3004209178-2021-00226
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2020
Device MODEL Number97715
Device Catalogue Number97715
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 Received01/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/21/2019
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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