BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2913154 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16904
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 10, 2012
    Report Date
    December 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THIS DEVICE WAS DISCARDED. 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 DURING A ROUTINE DEVICE CHECK, THE PATIENT COMPLAINED OF BEING SHORT OF BREATH AND TIRED. UPON INTERROGATION, IT WAS NOTED THE DEVICE HAD DECLARED END OF LIFE (EOL) APPROXIMATELY TWO MONTHS PRIOR. IT WAS INDICATED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20483 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R