BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK SQ

    MDR report key: 2045406 · Received April 8, 2011

    Report

    Report Number
    2124215-2011-02234
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE TOOK PLACE. THE LEADS WERE CHECKED WITH A PACING SYSTEM ANALYZER (PSA) WHICH SHOWED NORMAL PACING IMPEDANCES. THE PHYSICIAN DETERMINED THAT THIS LS-Q ARRAY LEAD WAS NOT COMPLETED FRACTURED, AND DECIDED TO USED THE SAME LEAD WHILE IMPLANTING A NEW DEVICE. DEFIBRILLATION TESTING WAS NOT PERFORMED. THE PHYSICIAN WANTED TO KNOW IF USING A NEW DEVICE WITH A PARTIALLY CONTINUOUS SUB-Q ARRAY WAS ACCEPTABLE. A BOSTON SCIENTIFIC TECHNICAL SERVICES REPRESENTATIVE REVIEWED DATA AND NOTED THAT HIS SUB Q-ARRAY MAY HAVE BEEN COMPROMISED BACK IN 2008. IN ADDITION, SINCE DFT'S HAVE NEVER BEEN PERFORMED NOR A SHOCK DELIVERED THE ONLY WAY TO CONFIRM THAT IMPEDANCES WERE SATISFACTORY WAS TO DO A SHOCK LEAD INTEGRITY TEST. TECHNICAL SERVICES SUGGESTED MONITORING THE PATIENT CLOSELY AS A RISE IN IMPEDANCES MAY INDICATE A COMPLETE LEAD FRACTURE. NO FURTHER INFORMATION WAS OBTAINED AND THIS LEAD REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP A SUSPECTED FRACTURE OF THIS SQ ARRAY LEAD WAS SUSPECTED. A REVISION PROCEDURE HAS BEEN PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK SQ IMPLANTABLE LEAD DTB CPI - DEL CARIBE 0049

    Patients

    Seq Age Sex Outcome Treatment
    1