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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 Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Loss of Data (2903)
Patient Problems Fatigue (1849); Malaise (2359)
Event Date 02/21/2021
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 who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The reason for call was the patient stated her settings were just jumping to different amplitudes. The patient stated she moved a few times and the stim just moved on its own without expecting this. Pt states she isn't feeling good and when she gets up the stim jumps up again. The patient stated she was tired and the stim had gone up. They stated nothing was uncomfortable and she is ok. Troubleshooting was performed and patient services (pss) walked the patient through the different settings for adaptive stim. The patient only had the upright position and everything else was gone. Pss directed the patient back to their healthcare provider (hcp) to have the system reorientated.

 
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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 Key11373617
MDR Text Key244119259
Report Number3004209178-2021-03175
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 02/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/28/2018
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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