BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 120404 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02217
    Event Type
    Injury
    Date Received
    September 8, 1997
    Date of Event
    June 24, 1997
    Report Date
    June 24, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION: RELIABILITY ASSURANCE TESTING OF BOTH THE VENTAK PRXIII (1720) AND THE MINI II (1763) REVEALED ELECTRICALLY DAMAGED OUTPUT CIRCUITS, WHICH IS CONSISTENT WITH THERAPY DELIVERY INTO A LOW IMEDANCE LEAD. IT WAS DOCUMENTED THAT DURING THE ATTEMPTED IMPLANT OF THE 1763 A LESS THAN 10 OHM SHOCKING IMPEDANCE WAS OBSERVED. THE ENDOTAK LEAD (0075-000184) WAS CAPPED AND A NEW LEAD WAS IMPLANTED ALONG WITH A NEW DEVICE (1763-803623).

    Description of Event or Problem · 1

    CPI RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAME IN FOR A CABG SURGERY. FOLLOW-UP TESTING PRIOR TO THE SURGERY (JUNE 24, 1997) REVEALED TWO DIFFERENT FAULT CODES. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE ON JULY 14, 1997, FOLLOWING THE CABG PROCEDURE. DURING THE REPLACEMENT PROCEDURE, THE SECOND DEVICE (MODEL 1763, SERIAL 802904) WAS UNABLE TO CONVERT THE PATIENT DURING DEFIBRILLATION THRESHOLD TESTING, EXTERNAL SHOCK WAS REQUIRED. THE SHOCKING LEAD IMPEDANCE MEASURED LESS THAN 10 OHMS. THE TRANSVENOUS DEFIBRILLATION LEAD (MODEL 0075, SERIAL 000184) WAS SUSPECTED TO HAVE AN INTERMITTENT ELECTRICAL SHORT. A NEW DEVICE AND LEAD WERE IMPLANTED. BOTH DEVICES MODELS 1720 AND 1763 ARE BEING SENT BACK TO CPI FOR ANALYSIS. THE CHRONIC LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 3.2 CONNECTOR LWS CARDIAC PACEMAKERS 1720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention THE DEVICE 0095 WAS IMPLANTED 14-JUL-1997| THE DEVICE 1763 WAS IMPLANTED 14-JUL-1997| THE DEVICE 1763 WAS IMPLANTED 14-JUL-1997| THE DEVICE 0075 WAS IMPLANTED 01-DEC-1994