BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2060101 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05914
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE LEFT VENTRICULAR LEAD'S THRESHOLDS MEASUREMENTS INCREASED RESULTING IN LOSS OF CAPTURE. IT WAS LATER DETERMINED THAT THE LEAD HAD PULLED BACK AS THE PATIENT IS A TWIDDLER. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPROTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention N119| 4591| 4469| 0184