BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2911189 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15935
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED NON-CAPTURE AT MAXIMUM OUTPUTS POST IMPLANT. IT WAS DETERMINED THAT THE LEAD HAD COMPLETED DISLODGED. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18692 ACUITY IMPLANTABLE HF LEADS OJX CPI - DEL CARIBE 4593

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R SD60-BP| MISMATCH| 4593| N161