BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 1853601 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14990
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD THIS LEAD GET RETURNED, IT WOULD BE ANALYZED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED 5.3CM FROM THE TERMINAL PIN. BOTH THE DISTAL AND PROXIMAL SEGMENTS WERE RETURNED. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN AND RING ASSEMBLY. THE SUTURE SLEEVE WAS NOT RETURNED WITH THE LEAD, HOWEVER ITS FOOTPRINT INDICATED A SUTURE SLEEVE WAS ANCHORED DOWN AT ABOUT 17.5 CM. TECHNICIANS PLACED A SIMILAR SUTURE SLEEVE ON THIS LEAD AND IT SHOWED THE DISTAL END WOULD BE ABOUT 19.2 CM FROM THE TERMINAL PIN. A BEND/CURVE WAS OBSERVED NEAR THE DISTAL END OF THE SUTURE SLEEVE WHERE AN X-RAY EXAMINATION REVEALED ALL INNER COILS WERE FRACTURED. A SECONDARY FRACTURE WAS ALSO IDENTIFIED ON SOME OF THE FILARS. THE LEAD DID NOT PASS RESISTANCE TESTING DUE TO THE FRACTURE. LABORATORY TESTING WAS ABLE TO CONFIRM THE ALLEGATION OF HIGH IMPEDANCE MEASUREMENTS BY CONFIRMING A FRACTURE IN THE CONDUCTOR COIL AT THE DISTAL AREA OF THE SUTURE SLEEVE TIE DOWN. IT WAS NOTED THAT SINCE THE OUTER INSULATION WAS INTACT OVER THE FRACTURE SITE THIS INDICATES THAT THE DAMAGE WAS NOT FROM THE CLAVICLE FIRST/RIB.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND A DECREASE IN SENSING AND NO CAPTURE WERE ALSO NOTED. A LEAD FRACTURE WAS CONFIRMED PER THE PHYSICIAN NEAR THE JUNCTION OF THE SUBCLAVIAN. THE LEAD WAS EXPLANTED.

    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 81 YR 4312| 4087| N119| 0158| 0041| H170| 4538| 4136