BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2051677 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03412
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINICAL EXAMINATION, A HOLE WITHIN THE DEVICE POCKET AREA WAS OBSERVED. THE PHYSICIAN INQUIRED HOW LONG THE HOLE HAD BEEN NOTABLE, WITH THE PATIENT STATING IT WAS DUE TO A MOTORCYCLE INJURY AND EVIDENT FOR APPROXIMATELY THREE MONTHS. THE FIELD REPRESENTATIVE STATED THE DEVICE WOULD BE PROACTIVELY EXPLANTED TO MITIGATE A POSSIBLE INFECTION. NO OTHER ADVERSE PATIENT EFFECTS REPORTED AND NO ALLEGATIONS AGAINST THE PRODUCT'S FUNCTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 4087| 1297| 4088