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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
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 manufacturer representative (rep) via a healthcare professional (hcp) regarding a trial patient.It was reported that the insulation on the lead began to sheer after the percutaneous extension and boot was placed.The lead was exposed.Trial patient had no side effects from this occurrence.The physician did say there seemed to be difficulty to slide the boot all the way on.As soon as physician saw that the exposed wire, it was removed and placed with a new one.No troubleshooting was done.Issue was resolved and component will be returned.No further complications were reported.
Additional Manufacturer Narrative
Analysis: analysis of the tined lead, 3889-28, interstim,us 28 cm (lot#: va1gzjd) found the butt joint of the outer insulation was separated at the proximal end of the lead.Electrical testing determined continuity was complete and no electrical shorts were identified between the circuits.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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) via a healthcare professional (hcp) regarding a trial patient.It was reported that the insulation on the lead began to sheer after the percutaneous extension and boot was placed.The lead was exposed.Trial patient had no side effects from this occurrence.The physician did say there seemed to be difficulty to slide the boot all the way on.As soon as physician saw that the exposed wire, it was removed and placed with a new one.No troubleshooting was done.Issue was resolved and component will be returned.No further complications were reported.

• 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: 6981105
• Report Number: 2649622-2017-12815
• Device Sequence Number: 1196676
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2017

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: 05/17/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1GZJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 11/20/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/01/2017; 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR