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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); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554)
Event Date 09/02/2020
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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient has been reprogrammed a couple times to optimize therapy and after recent reprogramming, stim was fine but when patient got home and started moving around, they noticed they felt like they were getting shocked. Caller stated patient reported to them that this has "happened before" but no time frame was provided. Caller mentioned that during reprogramming in office, stim would be at 1. 0 ma and patient would indicate stimulation felt "light" but then at 1. 1 or 1. 2 it was too strong for them. Caller stated that shortly after implant, patient was hospitalized with diverticulitis which including vomiting and dry heaving so caller didn't know if that may have caused an issue with the system. Caller stated managing health care provider (hcp) has ordered mri for the patient for this issue. Caller did not know patient's weight. The caller was not with the patient.
 
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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 Key11088172
MDR Text Key224086669
Report Number3004209178-2020-22689
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
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 Received12/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2020
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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