BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 93980 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-00814
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    November 5, 1996
    Report Date
    January 27, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) <MODEL NUMBER 1715, SERIAL 210449> AND A TRANSVENOUS DEFIBRILLATION LEAD EXPERIENCED CLINICAL SHOCKS AND WAS BROUGHT IN FOR EVALUATION. EVALUATION OF THE ICD SYSTEM (INTERROGATION OF STORED DATA IN MEMORY) IDENTIFIED LOW SHOCKING LEAD IMPEDANCE. IT'S SUSPECTED THAT THE DEVICE MAY HAVE BEEN DAMAGED DELIVERING THERAPY INTO A LOW IMPEDANCE LEAD. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO EXPLANT THE ICD. ON JAN. 27, 1997, A SECOND ICD <MODEL NUMBER 1746, SERIAL 601469> WAS ALSO EXPLANTED FOR LOW LEAD IMPEDANCE. THE LEAD <MODEL 0074, SERIAL 002992> WAS EXPLANTED AND ANOTHER LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1746 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention THE DEVICE 0074/002992 WAS IMPLANTED 24-OCT-1994| THE DEVICE 1763/802103 WAS IMPLANTED 27-JAN-1997| THE DEVICE 0095/202428 WAS IMPLANTED 27-JAN-1997| THE DEVICE 1715/210449 WAS IMPLANTED 24-OCT-1994