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

Model Number 97715

Device Problem Unstable (1667)

Patient Problems Dyspnea (1816); Loss of Range of Motion (2032); Unspecified Nervous System Problem (4426)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device available for evaluation: product id: 97755, serial#: (b)(4) , product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an external device and an implantable neurostimulator (ins).The reason for call was that the patient stated they had hell with this one for months.The controller doesn't hold the charge when they hold the recharge telemetry module (rtm) on their back.They stated "i have to hunch over with a pillow behind me and hold it there in a very uncomfortable position and it's very difficult to get it to communicate, and sometimes it takes hours and hours to charge." the ins tilted to the left to the spine, they could barely turn their left arm and barely breathe and they were getting error message needs attention.It was difficult to get excellent connection, if charge dies totally, it takes 4 hours to get 30%, and they had to stop and charge the controller, and start over and then charge her back, then takes 2 hours to charge the back.They were having a difficult time charging the implant.Patient services asked if there was any damage on the rtm and patient confirmed there wasn't, however the relay box on the rtm gets hot when they were recharging the implant.Pt was able to unlock the controller and the screen showed controller: 60% and implant 30%.Patient services confirmed that the controller was able to hold a charge and the green light was flashing indicating the controller was charging.The issue was not resolved through troubleshooting.

• 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: 11339272
• MDR Text Key: 232251717
• Report Number: 3004209178-2021-02772
• 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: 02/17/2021

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: 07/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/17/2021
• Date Device Manufactured: 08/08/2019
• 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: 60 YR