BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911789 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16272
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 14, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 DURING A ROUTINE FOLLOW-UP APPOINTMENT, EPISODES OF DEVIATED THERAPY IN THE VENTRICULAR FIBRILLATION (VF) ZONE WERE NOTED. SOME OF THE EPISODES WERE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT). THE ELECTROGRAM (EGM) SHOWED SPIKES AT COMPARABLE VOLTAGE TO THE INTRINSIC R-WAVE MARKED AS VF. THE SPIKES WERE REPRODUCIBLE WITH ARM MOVEMENTS. ADDITIONALLY, IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. AS THE DEVICE HAD ALMOST REACHED ELECTIVE REPLACEMENT INDICATOR (ERI),A REPLACEMENT PROCEDURE WAS SCHEDULED FOR THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE DEVICE WAS EXPLANTED AND THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16971 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R T177| 0175