BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3904578 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10042
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 12, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THIS PATIENT WAS RECENTLY SEEN IN THE HOSPITAL FOR EXPERIENCING A SYNCOPAL EVENT. THE DEVICE WAS INTERROGATED AND SHOWED LOSS OF CAPTURE (LOC) ON THIS RIGHT VENTRICULAR (RV) LEAD AS WELL AS SEVERAL PREMATURE ATRIAL CONTRACTIONS, UNDERSENSING AND LOW OUT-OF-RANGE (OOR) PACING IMPEDANCES. ADDITIONALLY THERE WAS NOISE WHICH LEAD TO PACING INHIBITION. AS A RESULT THE RV LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382441 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R S606| 4136| 4135