MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3889-28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The manufacturing representative via healthcare professional (hcp) reported that the electrodes pulled apart on the proximal part of the lead exposing the lead wires.It was appeared to be manufacturing defect.Hcp used a new lead from my trunk stock to replace the damaged lead.
Additional Manufacturer Narrative
Analysis of lead product: 3889-28, s/n: (b)(4) revealed that insulation broken between connectors #0 and #1 (at edge of connector #1), 1.2cm from proximal end.
Event or Problem Description
Product analysis is available now.
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): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6260570
• Report Number: 2649622-2017-00033
• Device Sequence Number: 10886767
• Product Code: EZW
• UDI-Device Identifier: 00613994601957
• UDI-Public: 00613994601957
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2017

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: 10/10/2020
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1BBYC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided; 02/14/2017
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/16/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR