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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97716
Device Problems Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Pain (1994); Burning Sensation (2146); Electric Shock (2554)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from the consumer via the manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that there was an issue with the recharging system. The patient experienced burning sensation/heating of the deep tissue surrounding the pocket device during the recharge session. There were no external contributing factors. Troubleshooting was performed. The recharger system was checked but it seemed to be okay. The action taken to resolve was the recharge velocity was reduced but without effect. The issue was not resolved at the time of this report. No surgical intervention, hospitalization, or injury occurred. Additional information was received a couple months later reporting when trying to recharge the patient felt burning and electrical over a line area to the left of the ins running vertical, internal not superficial. It was noted that the ins was implanted in the right buttock and the patient has a second ins implanted in the left buttock which everything was okay with. The following was done to identify the problem: increase distance between skin and antenna, turn off stimulation and perform recharge, and lower temperature and speed setting for the recharge session.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12385105
MDR Text Key268716071
Report Number3004209178-2021-13076
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeAR
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 09/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97716
Device Catalogue Number97716
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/02/2020
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: 08/30/2021 Patient Sequence Number: 1
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