BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR, DF-4 CONNECTOR

    MDR report key: 3903623 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12760
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BACKUP VVI MODE FOLLOWING EXCESSIVE CHARGING AND THERAPIES FOR VF. THE PATIENT ALSO RECEIVED INAPPROPRIATE SHOCKS. MOST OF THE SHOCKS WERE INEFFECTIVE INDICATING POSSIBLE SVT/CONDUCTED AF. DEVICE REPLACEMENT WAS RECOMMENDED DUE TO EXCESSIVE CHARGING. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380725 CURRENT PLUS VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1