BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX

    MDR report key: 1871661 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17697
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR ANALYSIS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT'S FAMILY ALLEGED THE BATTERY OF THIS PACEMAKER LEAKED WHICH IN TURN CORRODED THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION FROM THE PHYSICIAN STATED THERE WAS NO EVIDENCE OF A "LEAKING" DEVICE OR "CORRODED" LEAD. HOWEVER, THE RV LEAD WOULD NOT RELEASE FROM THE DEVICE HEADER DUE TO A STUCK SETSCREW. THE RV LEAD WAS CUT AND SURGICALLY ABANDONED. THE DEVICE WAS EXPLANTED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED BY COMPETITIVE PRODUCTS. NO SERIOUS ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMPANY HAS RECEIVED NO OTHER ALLEGATIONS REGARDING THIS PRODUCT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)