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

Model Number	305901
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
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 representative (rep) regarding a trial patient.It was reported that the lead kinked while the healthcare professional (hcp) was placing the lead through the foramen needle.Once kinked, the lead wouldn't properly feed through the needle.It was replaced with a new lead and the issue was resolved.There were no symptoms or further complications reported or anticipated.
Event or Problem Description
Additional information was received from a manufacturer¿s representative (rep) on (b)(4) 2017.The rep reported that the cause of the lead getting kinked was not determined.The rep reported that it almost appeared that the pne lead came out of its plastic hoop kinked.The rep reported that he couldn¿t confirm that this was the case or how the lead ended up kinked.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• MDR Report Key: 6599807
• Report Number: 8030670-2017-00002
• Device Sequence Number: 624225
• Product Code: EZW
• UDI-Device Identifier: 00613994925947
• UDI-Public: 00613994925947
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/28/2017

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: 01/30/2019
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 51023709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided; 06/01/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 06/28/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR