MAUDE Adverse Event Report: BOSTON SCIENTIFIC STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number UNKNOWN INS

Device Problems Power Problem (3010); Patient Device Interaction Problem (4001)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Event Description

It was reported that the patient's boston scientific ins may have interacted with their bladder stimulator, after it was put to charge.It was also reported that the patient felt stim in the wrong location and had little relief with their bladder symptoms.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17534880
• MDR Text Key: 321047497
• Report Number: MW5141780
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN INS
• Patient Sequence Number: 1