BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK P2

    MDR report key: 186648 · Received August 5, 1998

    Report

    Report Number
    2124215-1998-00985
    Event Type
    Malfunction
    Date Received
    August 5, 1998
    Date of Event
    July 8, 1997
    Report Date
    June 4, 1998
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS ENDOTAK TRANSVENOUS DEFIBRILLATION LEAD (0064) WAS REMOVED FROM SERVICE BECAUSE OF A LEAD FRACTURE. A CPI (0095) LEAD WAS IMPLANTED. CPI RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ELECTIVELY EXPLANTED JULY 08, 1997 AND RECEIVED FOR ANALYSIS ON APRIL 27, 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK P2 Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other THE DEVICE 0095/203070 WAS IMPLANTED 08-JUL-1997| THE DEVICE 0064/007820 WAS IMPLANTED 07-JUN-1994