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

Model Number NEU_ENS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2010

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a family member/friend regarding a patient's trial.It was reported that around the fall of 2010 the patient had an scs trial performed.It was stated that the trial failed.This failure was clarified to be that the leads were not placed properly and came out.The caller stated that they did not believe this was an issue with the trial device.No further complications were reported.

• Brand Name: UNKNOWN EXTERNAL SPINAL CORD 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
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8197490
• MDR Text Key: 131485761
• Report Number: 3007566237-2018-03710
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• 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 Age: 76 YR