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

Model Number	3889
Medical Device Problem Codes	Peeled/Delaminated (1454); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
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
Information was received from a manufacturer representative (rep) regarding a trial patient.It was reported that the lead insulation at the proximal end pulled away from the contacts exposing the 4 wires insulated wires in the lead.The rep further stated that the doctor placed the lead, connected the lead to the extension.After suturing the boot around the lead/extension the insulation pulled off of the lead.It was also indicated that there was no injury to the patient as a result of the lead problem.The lead was replaced with a new lead without issue.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
Additional Manufacturer Narrative
Device analysis coded above.
Event or Problem Description
Device analysis.
Additional Manufacturer Narrative
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: 6104254
• Report Number: 6000153-2016-00818
• Device Sequence Number: 19003209
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: 3889
• Device Catalogue Number: 3889
• Device Lot Number: VA19C6F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 12/28/2016
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 12/28/2016; 01/18/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1