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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 Disconnection (1171); Battery Problem (2885)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 08/16/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from a patient regarding their implantable neurostimulator (ins). Information was reported that the patient was able to charge her implant as well as her controller. She said both are at 100% and they don't deplete. The patient said that the implant has stayed at 100% for several days and isn't depleting. The patient was asked to check their system and it shows that the stimulation is on at 7. 2v, and the patient stated they fully charged up their implant on sunday. The patient said that the ins has not been helping her pain and said this started on sunday. She said she has recently lost weight (about 25lbs). The patient also noted no falls or trauma. Additional information was received from the patient and it was reported that there was a short. The device wire seemed to be disconnected at the pad. The device was replaced. The issue was resolved.

 
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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 Key10639292
MDR Text Key210390996
Report Number3004209178-2020-17357
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 10/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2019
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 Received09/28/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/13/2019
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: 10/06/2020 Patient Sequence Number: 1
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