MAUDE Adverse Event Report: MEDTRONIC; SACRAL NERVE STIMULATOR

Model Number SWP16-8646

Device Problem Material Integrity Problem (2978)

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

Event Date 10/28/2016

Event Type  malfunction  

Event Description

The surgeon was performing 2nd stage of nerve stimulator implant for patient.The rubber boot was removed, and surgeon noticed that the lead cover was damaged.There appeared to be exposed internal wiring.The lead was removed and replaced for safety precautions.

• Type of Device: SACRAL NERVE STIMULATOR
• Manufacturer (Section D): MEDTRONIC; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 6842158
• MDR Text Key: 84779655
• Report Number: 6842158
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2017

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: No Information
• Device Model Number: SWP16-8646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1