BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040691 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00588
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT FLUOROSCOPY REVEALED AN RV LEAD FRACTURE AT THE SUBCLAVIAN AREA. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM WAS PRESENTED WITH A BEEPING DEVICE. UPON INTERROGATION, A SHORT CIRCUIT CONDITION WAS DISPLAYED. ADDITIONALLY, THE DEVICE BATTERY WAS DEPLETED TO A POINT WHEN LEAD MEASUREMENTS COULD NOT BE PERFORMED AND THE DEVICE WAS CURRENTLY IN VVI MODE WITH A CHARGE TIME MEASUREMENT OF 45 SECONDS. A REVISION PROCEDURE WAS TO BE PERFORMED TO EXPLANT THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143874 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4470| N119| H125| 4542| 4517| 4471| 0184