MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problems Degraded (1153); Failure to Deliver Energy (1211); Charging Problem (2892); Connection Problem (2900); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional via a manufacturer representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that during ins replacement procedure, it was impossible to remove the existing lead from the ins.The issue was not resolved at the time of this report.The implant status was noted as implant-remains in service.The patient was alive with no injury.No further complications were reported or anticipated.

Event Description

Additional information was received from the manufacture representative reporting that the patient did not feel stimulation and was stimulating at very high settings.The patient had to recharge the system every 4 hours.The recharge frequency was too much of a burden for the patient, and this was the reason for ins replacement.The lead was a specify 2x8.During surgery the actions taken to resolve the event were: the setscrews were completely taken out of the header, ¿lavage with nacl 0.9%, and traction on the lead with a blunt instrument.There was brown corrosion in the header.One lead could not be removed from the header and the other lead was okay.The cause was unknown.The patient will be referred for a revision of the complete system to a neurosurgeon at a different hospital.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8712880
• MDR Text Key: 148444298
• Report Number: 3007566237-2019-01337
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention