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

Model Number	305901
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
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
The 2a manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that upon taking the lead out of the packaging, the hcp noticed, before attempting to implant, that the distal tip (~.5 cm from the end) had a bend in it.He briefly tested to see if it would go in the needle trocar to see, but as suspected, it would not pass.A different lead was used instead.There were no patient symptoms or affects associated with the event.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Analysis findings indicated that the distal end of the lead was bent at.5cm from the distal end.If information is provided in the future, a supplemental report will be issued.
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No new information was reported.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• MDR Report Key: 6907516
• Report Number: 8030670-2017-00006
• Device Sequence Number: 19057304
• Product Code: EZW
• UDI-Device Identifier: 00613994925947
• UDI-Public: 00613994925947
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2017

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: No Information
• Device Expiration Date: 10/06/2018
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 51020340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 10/09/2017; 10/30/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/12/2017; 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1