BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRX2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 95898 · Received May 8, 1997

    Report

    Report Number
    2124215-1997-01601
    Event Type
    Injury
    Date Received
    May 8, 1997
    Date of Event
    November 28, 1996
    Report Date
    December 19, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 3/12/97: THIS MDR WAS INTENDED TO BE FILED WITH THE MARCH 01, 1997 SUBMISSION, BUT WAS OVER-LOOKED BECAUSE OF A DECEMBER, 1997 YEAR LISTED IN ERROR. THE ALERT DATE SHOULD HAVE BEEN LISTED AS DECEMBER, 1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPMANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1715 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention THE DEVICE 4312/046796 WAS IMPLANTED 18-SEP-1991| THE DEVICE 4312/046797 WAS IMPLANTED 18-SEP-1991| THE DEVICE 1746/601888 WAS IMPLANTED 28-NOV-1996| THE DEVICE 0041/136712 WAS IMPLANTED 18-SEP-1991| THE DEVICE 0041/136715 WAS IMPLANTED 18-SEP-1991