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

Model Number 97715

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Information was received from a patient regarding an implantable neurostimulator (ins).The indication for use was non-malignant pain.It was reported that the patient stated they have been having trouble with the implant.The patient stated they can't get the implant to charge up at all.The patient added that they were able to connect to the ins to charge and it shows "recharging excellent," but the battery level never went up.The patient commented that they weren't sure if the implant was holding a charge before but now it won't charge at all.The manufacturer's patient services specialist (pss) walked the patient through removing the battery pack.The patient confirmed no physical damage on recharger cord, pins, controller connector port pins nor battery compartment pins.The patient reinserted the battery but the controller did not power on.The call was then disconnected.Pss called the patient back twice and left a voicemail for the patient to call back for further assistance.It was reported that the caller had a damaged/broken ac power supply cord and that was maybe why their equipment wasn't recharging.An email was sent to repair to replace the ac power supply.The patient called back and stated that they got the replacement ac power supply.The patient said when they go to charge the ins it said no device found.They tried to charge ins during the call and got no device found.They started prm and get 97 for a high number.

Manufacturer Narrative

Continuation of d10: product id 97745ac, serial# unknown, product type accessory.Section d information references the main component of the system.Other relevant device(s) are: product id: 97745ac, serial/lot #: unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19110738
• MDR Text Key: 340268056
• Report Number: 3004209178-2024-09121
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Date Device Manufactured: 05/24/2019
• 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
• Treatment: "SEE H11...."
• Patient Age: 51 YR
• Patient Sex: Male