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

Model Number 97715

Device Problems Overheating of Device (1437); Connection Problem (2900)

Patient Problem Burning Sensation (2146)

Event Date 10/01/2019

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

Event Description

Information was received via manufacturer representative (rep) from a patient who was implanted with a neurostimulator for unknown indication of use.It was reported that when patient was charging the ins the recharger heat up significantly and created a burning sensation.The ins would subsequently feel like it was heating up.Sometimes the controller/recharger would not find the ins when attempting to start a recharging session.The rep checked impedances and they were "good." the cable of the recharger did not look damaged but there was some normal wear on the cable near the recharging antenna.The rep provided the recharging duration from the recharging diary in the tablet: (b)(6) 26 min and (b)(6) 30 min.All other session were shorter than this and the patient reported that the heating occured during all recharging sessions including the short sessions that were <(><<)>10 minutes.This had happened to before with other patients and any previous instances were reported but she did not have report numbers for those reports.No further complications were reported.

Manufacturer Narrative

Product id 97755, serial# (b)(4).Product type recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) on january 29th, 2020.It was reported that the cause of the implantable neurostimulator (ins) and implantable neurostimulator recharger (insr) heating during recharge was not determined.A reprogramming was carried out with the patient, the impedances were checked and indicated they were normal, and the charging intervals were checked as well.A new recharger was sent to the patient in order to resolve the issues.There were no further complications or anticipations reported with this event.

• 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: 9629708
• MDR Text Key: 178348483
• Report Number: 3004209178-2020-01822
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Date Device Manufactured: 08/14/2018
• 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: 58 YR