BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3951040 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-11445
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ELECTROCAUTERY DAMAGE WAS NOTED IN SEVERAL PLACES. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. THE LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS. THE LEAD DID NOT PASS PRESSURES TESTS DUE TO THE ELECTROCAUTERY DAMAGE. NO LEAD ANOMALIES WERE NOTED OUTSIDE OF THE ELECTROCAUTERY DAMAGE CAUSED AT EXPLANT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS WERE AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427893 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 4549| 4592| 0181| 4470| N119| 4543