BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3339836 · Received September 10, 2013

    Report

    Report Number
    2938836-2013-06423
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    July 16, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF LOW HVLI AND PREMATURE BATTERY DEPLETION WAS VERIFIED VIA REVIEW OF THE DEVICE IMAGE. THE LOW HVLI MEASUREMENT OCCURRED AFTER THE DEVICE REACHED EOS. DURING TESTING, THE HVLI MEASUREMENTS WERE NORMAL. THE CAUSE OF THE LOW HVLI COULD NOT BE CONCLUSIVELY DETERMINED. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY VOLTAGE DROPPED FROM NORMAL TO EOS (END OF SERVICE) IN 1 MONTH. HIGH VOLTAGE LEAD IMPEDANCE DECREASE TO OUT OF RANGE WAS ALSO NOTED. THE DEVICE WAS REPLACED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453392 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 7120/65 (B)(4)