BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1945874 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-23488
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    May 11, 2004
    Report Date
    October 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY SIX YEARS LATER, THIS DEVICE REQUIRED EXPLANT DUE TO MIGRATION. DURING THE EXPLANT PROCEDURE, THERE WERE COMPLICATIONS REMOVING THE DEVICE PER THE PATIENT AND THE PROCEDURE SITE WAS VERY PAINFUL. NO OTHER ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    GUIDANT (NOW BOSTON SCIENTIFIC) RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WAS EXPERIENCING A CLICKING OR RUBBING SENSATION IN THE HEART AREA WHENEVER FLEXING MUSCLES IN UPPER CHEST AREA. GUIDANT RECEIVED ADDITIONAL INFORMATION THAT THE POCKET AREA WAS SWOLLEN. NO BLEEDING OR WEEPING FROM THE INCISION WAS PRESENT. THE PATIENT DID SEE THEIR FOLLOWING PHYSICIAN. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT INQUIRED IF SYMPTOMS ARE NORMAL. THIS WAS TO BE DISCUSSED FURTHER WITH THE PATIENT'S PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 0158| 5076| 1298| 1861