BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN

    MDR report key: 7358077 · Received March 21, 2018

    Report

    Report Number
    2124215-2018-04098
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED HIGH OUT OF RANGE SHOCK IMPEDANCES GREATER THAN 200 OMHS ON THE RIGHT VENTRICULAR (RV) CHANNEL. A REVISION PROCEDURE WAS PERFORMED, AND THE RV LEAD WAS EXPLANTED AND REPLACED. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201203 DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D021

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0158| D021