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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 Overheating of Device (1437); Insufficient Information (3190)
Patient Problems Burn(s) (1757); Burning Sensation (2146)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, product type: recharger. 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). It was reported that the paddle part of recharger telemetry module (rtm) and relay box in the rtm cord each got so hot that they burned the patient's fingers (patient confirmed red marks were left) and back (patient said a physical slight welt was left from being burned by recharger antenna). Patient said after recharger antenna got hot the controller sounded an alert that told her to 'disconnect the recharger antenna and call medtronic'. The patient didn't have rtm with her during call, patient is going to call back with serial number of rtm to get new replacement rtm ordered.
 
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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 Key11702716
MDR Text Key249069728
Report Number3004209178-2021-06429
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
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 Received07/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2019
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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