MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; Stimulator, spinal-cord, totally implanted for pain relief

Model Number NEU_INS_STIMULATOR

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97755 serial# (b)(6) product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6) , udi#: (b)(4); h3: analysis of the recharger telemetry module (rtm), model 97755 , s/n (b)(6) , revealed a rtm failure; the controller would not power on when the rtm was plugged in.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.G2.Foreign: br 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.

Event Description

It was reported that the recharger had issues.The recharger was no longer functioning.When connecting the recharger to the patient controller, it does not identify that was connected.The device did not fall, nor was there misuse.Troubleshooting was performed, connected a new recharger to the patient controller and it displayed the recharger positioning message together with the ins and it recharged normally.The recharger was replaced and the issue resolved.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: Stimulator, spinal-cord, totally implanted for pain relief
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18959048
• MDR Text Key: 339141052
• Report Number: 2182207-2024-02074
• Device Sequence Number: 1
• Product Code: LGW
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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...."