BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3241480 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11504
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS DISAGREED THE ALLEGATION. VISUAL OBSERVATIONS DETERMINED THERE WAS NOTHING WRONG WITH THE LEFT VENTRICULAR (LV) LEAD THAT WOULD CAUSE DISLODGEMENT. ADDITIONALLY, THE LEAD PASSED THE CONTINUITY TEST WITH MANIPULATION. NO CONFIRMATION WAS GIVEN THAT THE LEAD WAS EXPLANTED DUE TO HIGH THRESHOLDS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. A PRODUCT EXPERIENCE REPORT FORM NOTED THAT THERE WAS HIGH THRESHOLDS. THE LEAD WAS REMOVED AND WAS SUCCESSFULLY REPLACED WITH A COMPETITOR LV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339987 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 0185| 4592| N119| 4195| 4136