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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 Problem Migration or Expulsion of Device (1395)
Patient Problems Therapeutic Effects, Unexpected (2099); Reaction (2414)
Event Date 05/29/2020
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 healthcare provider via a manufacturer representative regarding a patient with an implantable neurostimulator (ins). It was reported the patient's battery was pushing its way out of their body. The patients pocket was revised once prior to this. The physician removed the ins, used extensions to cap off lead contact points and left the leads tied off in pocket for future reimplantation of ins. There were no reported environmental, external, or patient factors that may have led or contributed to the reported issue. It was stated this was a patient-specific reaction. It was noted there was no impedances on the leads and the patient reported 70% pain relief with the therapy. 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 Key10108879
MDR Text Key193415873
Report Number3004209178-2020-09534
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2020
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/10/2019
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: 06/02/2020 Patient Sequence Number: 1
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