MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM SACRAL NERVE STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Pt rec'd the interstim implant device in 2013 at an outside facility.She needed an mri for leg pain and because the device was towards the end of its lifespan, the pt opted to have it removed for the mri.The wire was able to be removed but there was a metal band missing from the most distal lead.Xray was performed and indicated the band was still present.The band was below the sacrum preventing further exploration and removal, so the md irrigated the site and closed the incision.A medtronic rep was present and made aware of the situation.

• Brand Name: INTERSTIM SACRAL NERVE STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 8208586
• MDR Text Key: 132046172
• Report Number: MW5082736
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2018

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 78