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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 Failure to Deliver Energy (1211); Insufficient Information (3190); Data Problem (3196)
Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Response, Decreased (2271)
Event Date 05/27/2020
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 concerning patient with an implantable neurostimulator (ins). It was reported patient charged overnight, and found stimulation was off this morning and had turned off in his sleep. He was able to connect and saw he is on program b with stimulation on. He says ins and controller are at 100 percent. The patient connected during the call and they reported being on program b and says stim is on, and on setting 1 at 0. 0v. The patient was instructed to raise stimulation up on setting 1 to 2. 7 and patient feels stimulation in his ribs. He says he normally feels it in his back. He says he doesn't remember what setting he was on before. He did say he is always on group b. The patient was instructed to try setting 2 and he found it was also at 0. 0v. He then raised to 2. 0v and feels in the right spot on his back now. The patient reported no falls and doesn't think he was around any emi. He says he doesn't have adaptive stim, and says he is always on the same setting for the last year and never has to make any changes. It is not clear why stim turned off but he did find in the "about" menu that it says there was an "error yesterday at 1243am and under that it 9/81 10/g on 2. Then it says 11/". It appeared everything was working during the call. The patient was redirected to follow-up with his healthcare provider (hcp) if it occurred again. 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 Key10102168
MDR Text Key192751405
Report Number3004209178-2020-09389
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 05/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received05/27/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/01/2020
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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