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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 Failure to Interrogate (1332); Communication or Transmission Problem (2896); Positioning Problem (3009)
Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Date 03/19/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that patient never had very good therapy results from the stimulator so they were still receiving "injections" from dr. (b)(6) who is the pt's "back doctor". Pt stated the injections are due to muscle spasms and the spasms cause the back pain. Pt stated they were told the pt really needs a fusion of their back. Pt stated they have the stimulator for this back pain and the therapy helped "maybe 50%" improvement. Pt stated their "back gave out" and the pt went into a rehab center around march. Pt stated their legs are wobbly and they have been using a walker. Pt stated they have had issues with walking since around march. Pt explained they do physical therapy, and pt's therapy issues got worse. Pt stated they left the rehab center in april. Pt stated they usually just do the bike and stretch at physical therapy. Pt stated they noticed for about a month its been harder to feel the stimulator battery in her upper buttock but from what they can tell, the battery feels flat and not tilted. Pt stated they have been having a harder time finding the "sweet spot" for maintaining connection for charging. Pt stated the charging duration has increased. When pt was asked if the controller displayed any messages while charging the stimulator, pt stated they recall seeing no device found sometimes and intermittently poor recharge quality. Pt stated they also no longer feel the stimulation in their back where they should. Pt stated they feel the stimulation go down their legs to their feet. Pt stated the stimulation will make their foot go numb. Pt stated they have muscle pain going down their legs. Pt stated when they cough they can still feel the stimulation in their back but does not feel the stimulation in the back besides while coughing. The patient was redirected to their healthcare provider to further address the issue. Pt reported they have an appointment on tuesday to check the device and work on programming with mdt rep (b)(6). The patient's relevant medical history included pt reported they weigh around (b)(6).

 
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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 Key12391864
MDR Text Key268934003
Report Number3004209178-2021-13146
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 08/31/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/14/2020
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 Received08/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/24/2019
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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