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

Catalog Number 97800

Device Problems Defective Device (2588); Failure of Device to Self-Test (2937); Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

Neurostimulator implant did not pass software testing with company rep at bedside.Per surgeon and rep, implant was explanted from pt.Placed in a sterile glove.A new device was opened and implanted, which worked properly.Circulating rn documented first implant as waste, to void duplicate charge for pt due to potential product malfunction from mfr.Medtronic rep took the faulty device for evaluation.Serial number: (b)(4) (wasted; (b)(4) (replacement, implanted).

• Brand Name: MEDTRONIC INTERSTIM STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 16689985
• MDR Text Key: 312863048
• Report Number: MW5116384
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/14/2023

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 Catalogue Number: 97800
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female