MAUDE Adverse Event Report: NEURO - VILLALBA INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3095-10
Medical Device Problem Codes	Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for bowel dysfunction/sacral nerve stim.It was reported that the patient had an mri around 2 weeks ago and now they are seeing a call your doctor screen.The patient could not recreate the code on the call so the letters were unknown.The patient also stated that they think that it is no longer working as they cannot communicate or feel it.It was recommended that they follow up with their healthcare professional.No further patient complications are anticipated or expected as a result of this event.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 9871557
• Report Number: 6000153-2020-00011
• Device Sequence Number: 11523212
• Product Code: EZW
• UDI-Device Identifier: 00613994100931
• UDI-Public: 00613994100931
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P080025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2011
• Device Model Number: 3095-10
• Device Catalogue Number: 3095-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR