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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 Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 08/04/2021
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

It was reported that recharger started becoming very hot while recharging the implant. The patient confirmed that they were actually physically burned from the recharger paddle. Patient stated that the burn was enough to turn their skin red and was almost to the point of blistering, but did not actually blister. The patient stated that they treated the burn with silvadene topical ointment. Patient explained that at first they thought they just had hives from an allergic reaction due to other causes and then the next day attempted to charge again and that's when they were burned. An email was sent to the repair department to replace the recharger.

 
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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 Key12312601
MDR Text Key266183775
Report Number3004209178-2021-12299
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
Report Date 08/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2020
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 Received08/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/10/2019
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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