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

Model Number 97715

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Environmental Compatibility Problem (2929)

Patient Problems Chest Pain (1776); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Electric Shock (2554); Insufficient Information (4580)

Event Date 01/01/2021

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 unknown indications for use.The reason for call was about a month ago the patient has been receiving electric shocks on their lips when they drink out of a glass bottle or a sippy cup.Pt also stated that starting around the same time about a month ago, their implant no longer held a charge like it use too.The pt use to go to bed with 90% ins charge and wake up with an 80% battery charge to their ins.Now when the pt goes to bed with the same ins charge of 90% they wake up with a 30% ins charge.The pt mentioned that they have turned down their stimulation from 4.0 to 2.0 because their chest aches and heart pounds when its any higher than 2.0.The caller was redirected to their medtronic representative.Pss emailed the pt's local medtronic representatives informing them about the reported events.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11305306
• MDR Text Key: 232224661
• Report Number: 3004209178-2021-02284
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Date Device Manufactured: 03/12/2019
• 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: 52 YR