BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATCH

    MDR report key: 4150918 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17841
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) PATCH WAS CONNECTED TO THE COMPETITOR'S DEVICE AND EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. AT THIS TIME, THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633438 PATCH IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0067

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 0067| MISMATCH| 0068