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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); Data Problem (3196)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 06/11/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from the patient¿s wife regarding the patient with an implantable neurostimulator (ins). It was reported that the patient¿s implant was not working for four days. They stated that they were not feeling stimulation and they would charge the ins in the morning to 100 percent and by the evening it would still be at 100 percent. Patient services assisted the patient with troubleshooting and it was determined that their therapy was at 0. 0 on p1 and p2 on group c. The patient increased stimulation on p1 and felt stimulation in their right leg and increased p2 and felt stimulation in their left leg. The patient stated that they were not sure how the stimulation went to zero. The patient stated that they felt stimulation now and indicated that the ins was both at 100 percent and their therapy was on. Troubleshooting resolved the reported issue. The event occurred on (b)(6) 2020. 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 Key10162540
MDR Text Key195708516
Report Number3004209178-2020-10489
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 06/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2020
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 Received06/15/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/16/2019
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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