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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 Overheating of Device (1437); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Pain (1994); Skin Inflammation (2443)
Event Date 05/12/2020
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), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient. It was reported that the recharger relay box was getting hot and the cord insulation was cracked/damaged where it would go into the coil. The patient stated that they realized on (b)(6) 2020 that they were unable to charge their implantable neurostimulator (ins) and that they would get a ¿no device found¿ error screen. The patient was redirected to the repair department and a replacement recharger was requested. No patient symptoms were reported and there were no complications. Indication for use is non-malignant pain. Additional information was received and it was reported that they hadn't changed anything to lead to the issue. When they took hold of the paddle their fingers touched the wires not knowing the wire was split open and they got blister-like burns on both fingers. The steps taken until they received a new recharger was to just not use it for a couple of days. They reported that it was very painful and they just stayed in bed. A new device was sent to them and they returned the bad one. 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 Key10131352
MDR Text Key194472825
Report Number3004209178-2020-09927
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2018
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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