BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2161258 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07487
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION WAS RECEIVED CONFIRMING THAT THIS LV LEAD WAS EXPLANTED AND WAS SUBSEQUENTLY DISCARDED IN THE OPERATING ROOM. NO FURTHER INFORMATION IS EXPECTED. THE INVESTIGATION REGARDING THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DID EXHIBIT LOSS OF CAPTURE. THE LOCAL AREA SALES REPRESENTATIVE STATED THAT EVIDENCE SUGGESTS THAT THIS LEAD HAD BECOME DISLODGED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 0185| 4549| 4555| 4469| E030| N119| 4592