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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 Problem Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)
Event Date 09/17/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97745 ; serial# unknown, product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Patient was implanted on (b)(6). Pt has been in excruciating pain ever since he woke up from the surgery. He had the worst pain when he came out of operating room that he ever had in his life. Hcp has been giving him some pain pills. Hcp said pt is through with pills. Pt saw the rep on (b)(6)to have his device programmed. Every time she set a mode pt was telling her it was stimulating his l hip and thigh. Every change was the same. The rep was not able to get the device to stimulate his back. His pain is in his back and he needs stim in his back. Pt went to er on (b)(6) and they gave him some relief to kill the pain. Pt had an apt with a rep yesterday but they texted and said something came up and he could not meet. Pt called rep and told him it was a bad day and next week pt is going to the mountains which will be another week of pain with no pain pills. Pt says they do not realize what pain he is in. The device costed him so much and he gets no relief. Pt is leaving to go to the mountains tomorrow and asking if there is a rep who could meet him there. Rep emailed the cause was not determined. The patient left town. The rep was to meet with the patient on (b)(6) 2020 when he returned. Rep relied from follow up sent. Rep reported root cause was not determined. Actions taken to resolve issue was reprogram. Issue has not been resolved, patient is consulting with physician. Patient called and reported the implant was explanted. Patient does not have the implant any longer. Implant was removed.

 
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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 Key12301393
MDR Text Key265824966
Report Number3004209178-2021-12159
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 08/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2021
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 Received08/05/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/14/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/10/2021 Patient Sequence Number: 1
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