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

Model Number 97715

Device Problems Disconnection (1171); High impedance (1291); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

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) for non-malignant pain on (b)(6) 2019.It was reported that the patient saw a settings not available message on the controller.The patient said she keeps the battery charged up.The patient was told to reduce the intensity down to zero and then increase intensity.The patient said she would call the rep.The issue started about a month prior to the report.No symptoms or further complications were reported.Additional information was reported on (b)(6) 2020 that the patient tried increasing her intensity and got the settings not available screen, which is something she's seen before and was told it wasn't an issue.The patient mentioned that she first saw the settings not available message screen 6 months ago or longer.The patient said she pressed ok at the bottom of the screen and it shows her battery levels, but when she selects program 1 and tries to increase intensity, it gives her the settings not available screen.No further information was reported additional information was received from the patient on (b)(6) 2020.It was reported that the cause of the settings not available message was unknown.The device was reset, which resolved the message.No further complications were reported or anticipated.Additional information was received from a manufacturer representative and a consumer regarding the patient on (b)(6) 2020.It was reported that the patient had been seeing a settings unavailable message on her patient controller.The manufacturer representative ran a connectivity and impedance check on (b)(6) 2020 which found that lead 0-7 had no connectivity and high impedances on contacts 0, 3, 4, 5, 6, and 7.There was an allegation that the lead was disconnected.There were no external or environmental factors noted to be related to the issue.The manufacturer representative changed the patient¿s programming only to use contacts 1 and 2 on the other lead.It was noted that the issue was not resolved at the time of the report; however, the health care professional has no further information regarding the event.No surgical intervention has occurred or is planned.

• 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: 10474150
• MDR Text Key: 205100322
• Report Number: 3004209178-2020-15070
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Date Device Manufactured: 03/23/2018
• 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: 71 YR