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

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

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) for spinal pain indications.The reason for call was pt reported that their implant battery was getting warmer periodically.Pt said this started a little over a week ago.Pt said they charge their implant every night at 7 pm like clockwork and after mid day or later in the day when their implant battery is getting to 50-60%, that is when the implant battery gets really warm.Pt said that they have a doctor and they have a pa that works with them.Pt said they work with their pa on a weekly basis and they contacted  rep on wednesday regarding the issue.Pt mentioned that they have also spoke to the rep since.Pt said the medtronic rep directed them to ps to see if ps had any suggestions.Pt said that the doctor did x-rays of their leads and their implant battery.Pt said that the images have come back.Pt said that rep was on vacation so they wondered who would cover for him if they needed to have surgery done to replace anything.The patient was redirected to their healthcare provider to further address the issue.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14565462
• MDR Text Key: 293086534
• Report Number: 3004209178-2022-07005
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2022
• Date Device Manufactured: 03/24/2019
• 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: 70 YR
• Patient Sex: Male