BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3100207 · Received May 8, 2013

    Report

    Report Number
    2124215-2013-07644
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    February 18, 2013
    Report Date
    April 2, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE ON THE HIGH VOLTAGE (HV) CHANNEL AND AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WHEN THE LEAD WAS PROGRAMMED RV COIL TO CAN. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE SHOCK IMPEDANCE HAD BEEN INCREASING FROM 70 TO THE LOW 100'S OVER THE LAST YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES RECOMMENDED PERFORMING ISOMETRICS AND PERFORMING A 1.1 JOULE AND 41 JOULE COMMANDED SYNCH SHOCK TO ASSESS HV LEAD INTEGRITY. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) WAS CONTACTED FOR ADDITIONAL INFORMATION. THE FR DID NOT HAVE ANY FURTHER INFORMATION AT THE TIME. THE SYSTEM REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201131 TELIGEN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION E110 147600
    201132 TELIGEN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION E110 147600

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H 0185.| 4470.| A155.| E110.| E110| 0185| 4470| A155