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

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); Sleep Dysfunction (2517)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).Recharger returned but analysis is not yet complete; a supplemental report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the "little black box" part of the recharger (rtm) "gets very hot sometimes" when the patient was charging.The patient added that it woke them up and was "burning my skin." the patient clarified that it "didn't leave a mark." repair noted that the rtm relay box was getting hot enough to burn the skin but it didn't leave a mark.A replacement rtm was sent to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from patient who stated that the replacement recharger resolved the burning sensation.

Manufacturer Narrative

Preliminary analysis found the recharge antenna was stuck on checking the recharger screen but further analysis found no issue with the external device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9617257
• MDR Text Key: 175923580
• Report Number: 3004209178-2020-01576
• 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,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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: 53 YR
• Patient Weight: 100