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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 97715
Device Problems Failure to Interrogate (1332); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 97755 lot# 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 who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient said they were recharging their ins and the recharger (rtm) started burning them so they pulled it off and then tried recharging again and 5 minutes later but it did the same thing (the patient mentioned they recharge twice a day). Pt said it was really hot where the cord met the paddle and the black transmitter box also got hot. Pt said it left 2 little red spots on their skin. The patient said that after the rtm got hot, when trying to recharge, now the controller displays that it cannot find the device. The patient explained going through passive recharge mode and said if they move the rtm slightly, the number jumps around from 17 to 100. The issue was not resolved. An email was sent to the repair department to replace the rtm.

 
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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 Key12309531
MDR Text Key266093108
Report Number3004209178-2021-12267
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
Report Date 10/01/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/17/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/08/2019
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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