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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); Insufficient Information (3190); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from the consumer via the manufacturer representative regarding a patient with an implantable neurostimulator (ins). It was reported that the adaptivestim (as) was not functioning correctly and the amplitudes were not adjusting. It was noted that when the manufacturer representative saw the patient, as was functioning and amplitudes were adjusting correctly. In the diary, the stimulation was off while the patient charged the ins regularly due to high density settings. On the mdt report, the time of the ins was changed to (b)(6) 2011 on the day of implant. Additional information received reported the amplitude was readjusted. The patient did not remember when the event first observed. The cause was unknown. No actions were taken due to the as was working correctly at follow up. The event was resolved. No further complications were reported or 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 Key10160796
MDR Text Key195581531
Report Number3004209178-2020-10452
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeSZ
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 06/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/16/2020
Is This An Adverse Event Report? No
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 Received05/26/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/18/2019
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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