BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 4131688 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17073
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    February 14, 2005
    Report Date
    July 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CHRONIC RIGHT ATRIAL (RA) LEAD EXHIBITED AN IMPEDANCE MEASUREMENT OF LESS THAN 100 OHMS ALONG WITH NO SENSING AND NO PACING. WHEN THE VOLTAGE WAS INCREASED, NOISE WAS ALSO SEEN. INSULATION DAMAGE WAS SUSPECTED THUS THE DEVICE WAS REPROGRAMMED VVI. APPROXIMATELY NINE AND A HALF YEARS LATER DURING THE DEVICE REPLACEMENT PROCEDURE FOR NORMALLY BATTERY DEPLETION, THE RA LEAD WAS SURGICALLY ABANDONED DUE TO THE LOW OUT OF RANGE IMPEDANCE MEASUREMENTS AND THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613150 PULSAR MAX II IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1280

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 4171| 1280| 1226| 4261| 4269| 1224