MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Overheating of Device (1437); Communication or Transmission Problem (2896)

Patient Problem Burn(s) (1757)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of concomitant products: product id 97755.Lot# serial# (b)(4).Implanted: explanted: product type recharger.Information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4).Date is approximate.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that they were having issues with consistently communicating with the stimulator when using the recharger.The patient stated they charge once a day or every other day, a few mins "here and there", and the stimulator is currently at 30%.The patient stated they tried moving the paddle of the recharger around and using passive recharge mode but the issue would not resolve.The patient stated the recharger, where the paddle and cord meet and at the relay box, would get "fire hot" and burned the patient's skin.The patient stated they put electrical tape around the cord, but the patient was still having issues with the recharger.An email was sent to the repair department to replace the recharger.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, 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 Key: 12526268
• MDR Text Key: 273123272
• Report Number: 3004209178-2021-14371
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR