BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780491 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12970
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 10, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THIS LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THERE WAS NO INFECTION, BUT A PATIENT ALLERGY. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO LOSS OF CRITICAL THERAPY OR ASYSTOLE GREATER THAN TWO SECONDS ASSOCIATED WITH THIS REPORTED ISSUE. THE SWELLING OF THE POCKET COULD NOT BE DETERMINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS SUSPECTED TO BE PART OF AN INFECTION DUE TO A HUGE SWELLING OF THE IMPLANT POCKET. THE PHYSICIAN ASSUMES AN ALLERGIC REACTION AFTER SEVERAL TESTS TO EXCLUDE INFECTION. IN ADDITION, THIS LEAD DISPLAYED AN EXIT BLOCK AND UNDERSENSING. A REVISION IS PLANNED, BUT NOT SCHEDULED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 0175| F110| 4096| 0185