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

Model Number	305901
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
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
Information was received from a healthcare professional via a manufacturer¿s representative regarding a percutaneous lead for a trial prior to implant.It was reported that prior to deploying the test lead, the doctor noticed the lead was bent at the tip; they still tried to use the lead and were unable to deploy.There was no patient injury and the lead was not used in the patient.No further complications were reported or are anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.Manufacturer representative reported they tried to use the lead on the patient, the stylet would not deploy the lead, due to the bend in it.The physician reportedly noticed the bend prior to putting it in, but thought it was worth trying.No further information reported.
Additional Manufacturer Narrative
Analysis of the lead (#60069683) identified that the body of the lead was stretched.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Lead was evaluated.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• MDR Report Key: 6927230
• Report Number: 8030670-2017-00007
• Device Sequence Number: 13791699
• Product Code: EZW
• UDI-Device Identifier: 00643169721166
• UDI-Public: 00643169721166
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 11/10/2017

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: 06/01/2019
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 60069683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/11/2017; 11/08/2017
• Initial Report FDA Received Date: 10/07/2017
• Supplement Report FDA Received Date: 10/13/2017; 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR