BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1951004 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23258
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 22, 2010
    Report Date
    March 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH A SET SCREW MARK ON THE TERMINAL PIN AND RING. VISUAL INSPECTION FOUND TISSUE IN THE HELIX MECHANISM. FURTHER DETAILED ANALYSIS REVEALED THAT THE OUTER INSULATION HAD RUPTURED THROUGH ON BOTH SIDES AT ABOUT 26.8 CM TO 28.2 CM FROM THE TERMINAL PIN. THE DAMAGED INSULATION HAS A ZIPPER-LIKE APPEARANCE AND THE OUTER COILS UNDERNEATH WERE SLIGHTLY FLATTENED. THE FIELD ALLEGATION OF DISLODGEMENT WAS NOT CONFIRMED. HOWEVER, ANALYSIS DID FIND INSULATION DAMAGE WITH THE COILS EXPOSED; THIS TYPE OF DAMAGE AND LOCATION (26.8 CM TO 28.2 CM FROM PIN) IS CONSISTENT WITH CLAVICLE FIRST/RIB ENTRAPMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE EXPLANT PROCEDURE FOR THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL LEAD DISLODGEMENT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE, A DISLODGEMENT OR EXIT BLOCK ARE SUSPECTED. A TEMPORARY PACER WAS PLACED AND BOTH LEADS WERE EXPLANTED. NEW RA AND RV LEADS WERE SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R S601| 5180| (B)(4)| MISMATCH| 4088| 4471