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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); Data Problem (3196)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 06/12/2020
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 consumer regarding a patient with an implantable neurostimulator (ins). It was reported that ¿right away¿ after getting their replacement controller (see pe (b)(4)) they noticed that the controller had the ¿wrong programming¿ on it. The patient asked if they needed to program their new controller. Patient services asked and the patient clarified that they were hurting again, they stated that the programming wasn¿t the same. They mentioned that group c was supposed to be on both sides and group a, they were not supposed to feel and was for their left side. They stated that they tried messing around with the setting to see if they would provide relief, but they hadn¿t worked. Patient services reviewed that programming was stored in the ins and not the controller and the patient was redirected to follow-up with their healthcare provider (hcp) to check their settings and possibly reprogram them. The patient stated that they would reach out to their rep. The event occurred in (b)(6) 2020. No further complications were reported/anticipated.

 
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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 Key10192024
MDR Text Key196441123
Report Number3004209178-2020-10983
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 06/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2020
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 Received06/22/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/05/2019
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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