BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2780194 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12485
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 2, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF LIGHTHEADEDNESS AND FEELING DIZZY; IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE SYNCOPE. A DEVICE INTERROGATION DID NOT REVEAL ANY ISSUES. THE FIELD REPRESENTATIVE STATED THAT TWO HOURS LATER, HE WAS ASKED TO RETURN TO THE HOSPITAL AS A TELEMETRY STRIP SHOWED ASYSTOLE FOR 4 TO 5 SECONDS. ANOTHER DEVICE INTERROGATION WAS PERFORMED WITHOUT ANY SIGNIFICANT FINDINGS. AFTER MONITORING THE PATIENT, THE FIELD REPRESENTATIVE OBSERVED A 3 TO 4 SECOND PAUSE ALONG WITH RIGHT VENTRICULAR (RV) LOSS OF CAPTURE AND OVERSENSING OF NOISE LEADING TO PACING INHIBITION. THE OVERSENSING OF NOISE WAS ABLE TO BE RECREATED WITH ISOMETRICS, POCKET MANIPULATION AND ARM MOVEMENTS. A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED DUE THE LOSS OF CAPTURE AND INSULATION DAMAGE. IT WAS NOTED THAT THE CAUSE OF THE LOSS OF CAPTURE WAS UNABLE TO BE DETERMINED, HOWEVER NO LEAD TO DEVICE CONNECTION ISSUE WAS SEEN DURING THE REVISION PROCEDURE. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 4137| 4135| S606