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

Model Number 97715

Device Problems Insufficient Information (3190); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/28/2020

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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported the patient was currently on group b with program 1 around 3.8/3.9ma and program 2 at 3.1ma.The patient stated they didn't press any buttons but they noticed that both programs were set to 0.0.The patient stated they had maintained the battery charge for the ins, noted it was 70% that morning, and was able to increase stimulation.The patient inquired what would cause the stimulation to go to 0.0.The patient confirmed they were reprogrammed and was programmed with adaptive stim on their settings.The patient stated ever since programming they had noticed therapy relief to a degree but indicated they did not like adaptive stim.It was reviewed the likelihood the stimulation changed due to adaptive stim.The patient went in to each program and confirmed each program was on, program 1 was set to 3.8ma, program 2 was set to 3.1ma, and that adaptive stim was turned off for both programs.Screen use was reviewed and the patient locked and unlocked the controller and double checked the settings.The patient was encouraged to follow up with their healthcare provider if they continued to have concerns regarding adaptive stim.No further complications were reported or anticipated.

• 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: 10145872
• MDR Text Key: 194973133
• Report Number: 3004209178-2020-10191
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/11/2020
• Date Device Manufactured: 07/13/2018
• 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: 68 YR