BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR

    MDR report key: 3090177 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01154
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    October 8, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE IDENTIFIED AN ANOMALOUS COMPONENT. THIS COULD ACCOUNT FOR THE FIELD OBSERVATION OF EXTENDED CHARGE TIME. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A VIBRATORY ALERT. INTERROGATION SHOWED THE ALERT WAS TRIGGERED DUE TO EXTENDED CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191970 CURRENT PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention