MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION LEAD INTERSTIM II 28CM TINED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Lot Number VA2LOMP

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

During sacral nerve stimulator removal, the old lead fragmented and a portion remained in the bone.It was unable to be removed.Policy followed for notifying patient.

• Brand Name: LEAD INTERSTIM II 28CM TINED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 16938360
• MDR Text Key: 315290353
• Report Number: 16938360
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/24/2023,04/20/2023

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
• Device Lot Number: VA2LOMP
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male