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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 Overheating of Device (1437)
Patient Problems Burning Sensation (2146); Injury (2348); Skin Inflammation (2443)
Event Date 08/03/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins). It was reported the patient was charging their ins on (b)(6) 2020 and the recharger was very hot and pulled some skin off. The patient now had a blister where the recharger was on their back. It was noted the patient notified their health care provider about the issue. A new recharger was requested. 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 Key10373286
MDR Text Key201887551
Report Number3004209178-2020-13559
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,Followup,Followup
Report Date 11/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/14/2019
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 Received11/02/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/20/2018
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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