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	03/14/2017
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¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).The rep reported that the lead fractured during the removal of the lead introducers and bent tip stylet.The rep reported that the lead fractured just below the last blue mark near the electrodes where the bent tip stylet connection was.The rep reported that the patient did not experience any symptoms related to this lead, as it was immediately taken out and a new lead was implanted.No further complications anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.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
No new information received.
Additional Manufacturer Narrative
Analysis of the lead va1d8ka revealed that the butt joint of the outer insulation was separated at the proximal end of the lead.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.The outer insulation is separated at the butt joint and the conductors were stretched.This damage is consistent with the note in the returned paperwork which stated that the stylet was not released from the lead during removal of the introducer and stylet.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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: 6409616
• Report Number: 2649622-2017-02487
• Device Sequence Number: 13589100
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/16/2017

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: 12/09/2020
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1D8KA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/10/2017; 05/10/2017
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 04/14/2017; 05/16/2017; 10/02/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR