BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3050039 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04981
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. DURING THE REVISION PROCEDURE IT WAS REPORTED THERE WAS A DROP IN RATE WHICH RESULTED IN THE PATIENT NEEDED TO BE EXTERNALLY SHOCKED. THE PHYSICIAN ELECTED TO USE THE DEVICE AS A TEMPORARY PACER UNTIL A REPLACEMENT DEVICE COULD BE PLACED. THIS IS CONSIDERED OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151992 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 0154| 1488T| N141| E110| 4554| 1861