BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780958 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13023
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 24, 2012
    Report Date
    April 2, 2024
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD REPRESENTATIVE WHO LATER REPORTED THAT THE CLINIC CHECKED THE PATIENT AND EVERYTHING APPEARED TO BE FINE. SHOCKS WERE NOTED FOR VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION WITH NO FURTHER ACTION TAKEN AT THIS TIME. NO LEAD TESTING OR INDUCTIONS WERE PERFORMED.

    Additional Manufacturer Narrative · 1

    EVENT CLARIFICATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE. HOWEVER, NOTHING FURTHER HAS BEEN RECEIVED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A HIGH VOLTAGE ON THE SHOCK LEAD DURING A CHARGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 66 YR Male 0185| A155| T175| T175| A155| 0185