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

Model Number	3889-28
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a consumer via a manufacturer representative (rep).It was reported that the patient experienced a return of symptoms.Programming changes were made at the office and there were no noted environmental, external, or patient factors that contributed to the issue.The patient had a lead revision and the product was explanted.It was indicated that the issue was resolved at the time of report.No further complications were reported or were expected.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a rep.It was reported that the cause of the lead revision was a loss of efficacy.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: 6601460
• Report Number: 6000153-2017-00023
• Device Sequence Number: 746452
• Product Code: EZW
• UDI-Device Identifier: 00613994601957
• UDI-Public: 00613994601957
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2017

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: 04/06/2015
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: V699552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided; 05/31/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 06/26/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR