MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION BLADDER BATTERY / ON INTERSTIM DEVICE; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problems Self-Activation or Keying (1557); Vibration (1674)

Patient Problem Discomfort (2330)

Event Date 09/07/2018

Event Type  Injury  

Event Description

About 10 days after the device was implanted on my backside, it has tended to speed up on its own at night time, so it makes it impossible to fall asleep.It is impossible to adjust to something vibrating so much at night time inside your body.

• Brand Name: BLADDER BATTERY / ON INTERSTIM DEVICE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne-rcw225; minneapolis MN 55432
• MDR Report Key: 7973410
• MDR Text Key: 124091502
• Report Number: MW5080587
• 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: Patient
• Type of Report: Initial
• Report Date: 10/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR