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

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 06/01/2018

Event Type  Injury  

Event Description

Caller was implanted with the interstim neural sacral stimulator for bowel incontinence in (b)(6) 2018.Caller stated device is not working, she turns it on but will not work.

• Brand Name: INTERSTIM NEURAL SACRAL STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 8074257
• MDR Text Key: 127353608
• Report Number: MW5081279
• Device Sequence Number: 0
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 91