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 Deliver Energy (1211); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problem Electric Shock (2554)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 977c165, serial# unknown, implanted: (b)(6) 2019, explanted: (b)(6) 2024, product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977c165, 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.

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that there were high impedances on the day of surgery.High impedances between 27,000-40,000.A loss of stimulation and shock was also noted.  they did troubleshooting with the wens to see if there was a connection problem as well and there was.  the paddle lead and battery were replaced.The issue was 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: 18939435
• MDR Text Key: 338076979
• Report Number: 2182207-2024-01937
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 02/19/2024
• 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 Outcome(s): Required Intervention
• Patient Sex: Male