BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2173281 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11102
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    October 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    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 OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    SUBSEQUENT INFORMATION WAS RECEIVED THAT INDICATED ADDITIONAL LSS'S HAD BEEN TRIGGERED. THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP WHERE THE LEAD IMPEDANCE MEASUREMENT WAS NOTED TO HAVE BEEN LOW. NOISE WAS ABLE TO BE RECREATED WITH ISOMETRICS. THE LEAD WAS REPROGRAMMED BACK TO BIPOLAR. THE SYSTEM WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS SEEN FOR A SURGICAL INTERVENTION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE DEVICE REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINIC FOLLOW UP, THIS RIGHT ATRIAL (RA) LEAD AND PULSE GENERATOR (PG) INDICATED THAT A LEAD SAFETY SWITCH (LSS) HAD OCCURRED. THE DATE OF OCCURRENCE AND VALUE OF THE IMPEDANCE MEASUREMENT WAS UNKNOWN. NOISE WAS ALSO SEEN IN UNIPOLAR CONFIGURATION. THE DEVICE WAS REPROGRAMMED TO BIPOLAR CONFIGURATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 1270| S606| 4034| 4271