BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2913735 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00355
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 28, 2012
    Report Date
    July 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. MICROSCOPIC VISUAL INSPECTION FOUND NO IRREGULARITIES. THE HEADER WAS COMPLETELY INTACT. ALL LEAD IMPEDANCE MEASUREMENTS WERE GOOD. BATTERY DEPLETION WAS DUE TO COMPROMISED LOW-VOLTAGE CAPACITOR WHICH RESULTED IN A HIGH CURRENT CONDITION. IT WAS FOUND OUT THAT THE BATTERY BYPASS CAPS WERE LEAKY.

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A FAULT CODE FOR VOLTAGE TOO LOW FOR REMAINING LONGEVITY AND WAS STILL HAVING ISSUE WITH HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENTS. THIS ICD WAS EXPLANTED AND HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND NON-BSC RIGHT VENTRICULAR (RV) LEAD DISPLAYED SHOCK IMPEDANCE MEASUREMENTS IN THE LOW 60 OHMS RANGE, THEN GREATER THAN 125 OHMS. THE PATIENT WITH THIS DEVICE SYSTEM WAS BROUGHT IN FOR FURTHER REVIEW. ISOMETRIC AND POCKET MANIPULATION EXERCISES WERE PERFORMED, HOWEVER, NO NOISE WAS OBSERVED. DEFIBRILLATION THRESHOLD (DFT) TESTING AND COMMANDED SHOCKS WERE DELIVERED WITH ALL MEASUREMENTS WITHIN ACCEPTABLE LIMITS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20486 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 210 MO Hospitalization| L| R 4469| E110| 7122