BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3213185 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09956
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    October 1, 2011
    Report Date
    January 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P960040/S155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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.

    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.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND LEAD REMAIN IN-SERVICE. 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 VIA REMOTE MONITORING THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CLINIC REVIEWED THE LEAD DATA AND WILL CONTINUE TO MONITOR THE LEAD AND DEVICE. TWO YEARS LATER ANOTHER REMOTE MONITORING ALERT WAS NOTED FOR A HIGH RV SHOCK LEAD IMPEDANCE MEASUREMENT. THE CLINIC REVIEWED THE MEASUREMENTS AND WILL CONTINUE TO MONITOR THE LEAD AND DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. DEFIBRILLATION THRESHOLD TESTING WAS SUCCESSFULLY PERFORMED AND THE RECORDED POST-SHOCK IMPEDANCE MEASUREMENT WAS 72 OHMS. NO FURTHER INTERVENTION WAS UNDERTAKEN AND THE DEVICE/LEAD SYSTEM REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S MONITORING SYSTEM DETECTED ANOTHER RED ALERT FOR HIGH SHOCK IMPEDANCE IN EARLY-OCTOBER 2013. THE LOCAL REPRESENTATIVE WAS NOTIFIED OF THE RED ALERT. THE DATA FROM THE ALERT HAD ALREADY BEEN REVIEWED BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313459 TELIGEN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION E102 247888

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Hospitalization| R| O 0180| E102| T135| E102| T135| 0180