MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number NEU_INS_STIMULATOR

Device Problems Unintended Collision (1429); Energy Output Problem (1431)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 04/26/2016

Event Type  Injury  

Event Description

Information was received from a patient with an implantable neurostimulator (ins).It was reported that the patient was in an accident on their motorcycle and hurt their left arm and left foot.The patient reported that they had to ¿slice him open and put cadaver parts in him.¿ the patient reported that they stopped getting relief from their ins in 2016.The patient noted that they were looking at getting a pump implanted.No further complications are anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional review of original source information found that the patient had a spinal cord stimulation system put in, in 2005.The date that the patient had his motorcycle accident remains unknown.Additional information was received from a consumer regarding the patient on (b)(6) 2018.It was reported that the patient had the stimulator placed about 10 years ago.The patient noted that the stimulator still works, but starting about 3 years prior to the report, the stimulation therapy stopped working for the patient¿s pain.The patient is working with a physician and plans to have a fentanyl pain pump implanted on (b)(6) 2018.When the patient is having the pump placed, he plans to remove the implantable neurostimulator, but leave the leads in due to potential scar tissue.The patient mentioned that he had a minor stroke about 6-7 years prior to the report and did not confirm if the stroke was related to the stimulator.The patient¿s pre-existing medical conditions include being run over by a forklift and has been on fentanyl for 20 years at 200 micrograms.This was the reason for implant.

• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6530650
• MDR Text Key: 74102699
• Report Number: 3007566237-2017-01645
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention