FLEXTEND
Report
- Report Number
- 2124215-2010-17796
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- September 2, 2010
- Report Date
- November 9, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, HELIX MECHANISM DIFFICULTY WAS NOTED. TESTING REVEALED THE INNER COIL TO TERMINAL PIN WELD WAS FRACTURED AT APPROXIMATELY 12 MM FROM THE TERMINAL PIN. EXAMINATION OF THE COIL SIDE OF THE FRACTURE SHOWS THAT ALL THREE OF THE COIL FILARS WERE WELDED. BOTH SIDES OF THE FRACTURED SURFACE WERE COVERED WITH DUCTILE DIMPLES INDICATING FAILURE BY OVERLOAD FORCE THAT EXCEEDED THE STRENGTH OF THE MATERIALS. THE INNER CONDUCTOR COIL FRACTURE APPEARS TO BE THE RESULT OF OVER-TORQUE APPLIED TO THE TERMINAL PIN DURING ATTEMPTED HELIX MECHANISM RETRACTION AT EXPLANT.
THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT PRESENTED WITH RATES IN THE 30'S. A CHEST X-RAY REVEALED BOTH THE ATRIAL AND RIGHT VENTRICULAR (RV) LEADS HAD DISLODGED. IN A REVISION PROCEDURE, THE HELIX OF THE ATRIAL LEAD WAS NON-FUNCTIONAL, THEREFORE THIS LEAD WAS EXPLANTED AND REPLACED BY A NEW LEAD. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | 4088| 4087| S404 |