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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 97715
Device Problems Intermittent Continuity (1121); Disconnection (1171); Failure to Deliver Energy (1211); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Application Program Problem (2880); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Insufficient Information (4580)
Event Date 06/24/2021
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 pt reported they need to be reprogrammed. Pt reported they were at a physical therapy appointment for their hip sometime around (b)(6) 2021 and their physical therapist was stretching pt's knee to their chest and their device "went crazy". Pt stated they could feel stimulation up into their arm pits and down the sides of their legs. Pt stated they were programmed with 3 different groups so they tried changing groups to see if that would help and it didn't. Pt stated they were reprogrammed by a manufacturing representative (rep) sometime around the end of (b)(6) 2021 and the reprogramming didn't help. Pt stated after being reprogrammed their symptoms are not being relieved and they feel the same whether or not stimulation is turned on or off. Pt noted that rep reprogrammed them so their rate was 1000 and intensity was 7. Pt also mentioned that "settings unavailable" displays on their controller ever since being reprogrammed and their stimulation has been turning off by itself. Pt commented that this is their second device and the therapy has always completely eliminated their pain up until recently and they're able to golf again. Pt also noted that they've had a hip replacement in the past. Pt stated they have an upcoming doctor appointment on (b)(6) 2021 at 9am and would like a different rep to meet them at the appointment if possible for reprogramming. Ps emailed field reps for visibility. Additional information was received from the patient and it was reported that patient called and stated had adjustment and therapy seem ok and after couple days therapy turned off, and when he stand up and walk he felt high rate of stimulation that grabbed him. Patient stated something went wrong during his physical therapy session because he was feeling vibration where he didn't feel stimulation before in the armpits and legs. Patient stated he thinks there is a disconnection and more needs to be done. Patient stated he spoke with two manufacturing representatives (rep)s last week but they don't seem very anxious to help him. Patient asked what does he need to do to get someone to assist him.

 
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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 Key12375408
MDR Text Key268438228
Report Number3004209178-2021-13001
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 08/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2018
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 Received08/16/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/09/2017
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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