BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3760858 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08829
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    February 7, 2012
    Report Date
    February 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    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

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED PACING IMPEDANCE MEASUREMENTS FROM 1,200 OHMS TO GREATER THAN 2,000 OHMS. NO OTHER LEAD ISSUES WERE REPORTED INITIALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RESOLUTION HAS BEEN REQUESTED FROM THE FIELD AND IT WAS LATER REPORTED THAT BOTH THE RV LEAD AND RIGHT ATRIAL (RA) LEAD APPEARED TO HAVE BEEN SLIGHTLY PULLED BACK. SENSING AND PACING MEASUREMENTS WERE WITHIN RANGE ON THE RV LEAD AND NOTHING ON IMAGING SUGGESTED A LEAD ISSUE. HOWEVER, THE PHYSICIAN ELECTED TO REVISE THE RV LEAD. DURING THE REVISION THE RV HELIX WOULD NOT EXTEND ACCORDING TO THE FLUOROSCOPY IMAGES AND THEREFORE THE LEAD WAS EXPLANTED. THE LEAD WILL NOT BE RETURNED AS IT HAD BEEN SEVERED INTO PIECES. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240153 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 0185| 4087| E110| A155