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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 Energy Output Problem (1431)
Patient Problems Headache (1880); Vomiting (2144); Insufficient Information (4580)
Event Date 04/12/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The patient reported that since implant, whenever the stimulation is turned on they were experiencing severe headaches that would cause them to throw up and urinary issues as well.   the patient stated that during the trial they didn't get the headaches and would have the setting at 2. 6 and could barely feel stimulation.   with the permanent implant, stimulation felt much stronger at 2. 6, so the patient has to turn stimulation down but the headaches don't resolve.    they also tried the other programmed groups without resolve.   their doctor redirected them to get reprogramming from a manufacturer representative (rep).   they were redirected back to the doctor to schedule the appointment with the rep.   the patient met with a rep on (b)(6) 2021 and the rep performed reprogramming by giving the patient new settings.   the patient was told to try out the new settings; issue was not yet resolved. Additional information was received from the manufacturer representative (rep). The patient had the removed on (b)(6) 2021.

 
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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 Key12375154
MDR Text Key268450492
Report Number3004209178-2021-12999
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device Was Involved in the Event
1 Patient Was 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 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 Manufactured03/12/2021
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: 08/26/2021 Patient Sequence Number: 1
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