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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient (pt) reported that in the last couple of days, they have felt "wonky".Pt explained that they have had no energy, lots of pain, sleep was off, and stability was off.The patient noted that they are able to recharge the implantable neurostimulator and that they typically recharge when the implantable neurostimulator reaches 30% charge or lower.They usually recharge on saturday or sunday, and that when they are more active, they need their ins. the patient unlocked the controller at the time of the report, and the pt confirmed the stimulation was off. it was reviewed with the patient how to turn the ins back on, and the pt confirmed that they were successful with turning the therapy on (pt noted they felt stimulation again).Pt reported that this is not the first time that they have noticed the ins turning off.Pt reported that in at least the last 6-7 months, they have noticed this issue, and they had to see the hcp (health care professional)  to "get the funkyness out." pt stated that they noticed this issue after physical therapy.Patient services reviewed controller capabilities, importance of keeping the ins charged, tracking the issue in a diary, and to follow-up with the health care professional.

• 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: 11771638
• MDR Text Key: 251468354
• Report Number: 3004209178-2021-07168
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Date Device Manufactured: 10/30/2018
• 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