BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3223490 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-09750
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    October 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P960040/S155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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) ELICITED INCREASED RIGHT VENTRICULAR (RV) SHOCK LEAD IMPEDANCES OVER A PERIOD OF TIME FROM 60 TO 90 OHMS. PACING THRESHOLDS WERE ALSO NOTED TO HAVE INCREASED SLIGHTLY DURING THAT TIME. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED PERFORMING ISOMETRICS WHILE MEASURING OTHER SHOCK CONFIGURATIONS TO ASSESS SYSTEM INTEGRITY, DURING WHICH TIME HIGH OUT-OF-RANGE MEASUREMENTS GREATER THAN 125 OHMS WERE NOTED ON THE RV LEAD TO DEVICE SHOCK VECTOR. ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE INDICATING THAT THE CAUSE OF HIGH SHOCK IMPEDANCE IS UNKNOWN AND THAT THERE ARE NO COMMANDED SHOCKS THIS TIME. ALSO, THE FIELD REPRESENTATIVE WAS RECOMMENDED TO FOLLOW THE PATIENT AND THEY WILL GET AN ALERT IF THE SHOCKING IMPEDANCE MEASUREMENT WOULD REACH GREATER THAN 125 OHMS. THE DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED ANOTHER ALERT WAS TRIGGERED FOR HIGH OUT OF RANGE SHOCK IMPEDANCES. FURTHER REVIEW NOTED THE SHOCK IMPEDANCES HAD STARTED TO DECREASE SLIGHTLY IN (B)(4) 2017, BUT THEN RETURNED TO STABLE VALUES OF 110-120 OHMS IN (B)(4) 2017. THE VALUES THEN SPIKED TO AN OUT OF RANGE VALUE OF GREATER THAN 125 OHMS. THE PATIENT IS BEING MONITORED AT THIS TIME. THE PRODUCTS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THIS PATIENT WAS BROUGHT IN AND A COMMANDED SHOCK WAS PERFORMED. THE SHOCK IMPEDANCES WERE WITHIN AN ACCEPTABLE RANGE AND WERE 71 OHMS, SO THE PATIENT WILL BE MONITORED. AT THIS TIME, THE PRODUCTS REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323673 TELIGEN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION E102 251677

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 0185| E102| T175| E102| 0185| T175