BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 4140117 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17508
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE HOSPITAL DUE TO SYNCOPE. AN ELECTROGRAM REVEALED THAT THERE WAS PACING INHIBITION INVOLVING THE PATIENT¿S DEVICE AND RIGHT VENTRICULAR (RV) LEAD WHICH LED TO ASYSTOLE OF GREATER THAN TWO SECONDS. SURGICAL INTERVENTION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED WITH THE RV LEAD HOWEVER THE PHYSICIAN SUSPECTED THE INHIBITION MIGHT HAVE BEEN DUE TO AN INCOMPLETE FRACTURE OR SOME FORM OF DEVICE FAILURE. THE RV LEAD WAS SURGICALLY ABANDONED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619822 THINLINE IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 430-10

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R MISMATCH| 430-10| 1394| 292-09Z