BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913102 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16594
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 9, 2012
    Report Date
    November 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INITIAL ANALYSIS CONFIRMED THAT THE DEVICE HAD NO TELEMETRY AND AUTOMATED TESTING TO EVALUATE THE FUNCTIONS OF THE DEVICE WAS UNABLE TO BE PERFORMED. THE TITANIUM CASE WAS OPENED, AND MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO COMPROMISED LOW VOLTAGE CAPACITORS THAT ARE CONNECTED TO THE DEVICE¿S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE. ON AUGUST 29, 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS A PART OF THE IDENTIFIED POPULATION.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON WHETHER OR NOT THIS DEVICE WAS EXPLANTED WERE UNSUCCESSFUL. CURRENTLY OUR RECORDS INDICATE THAT THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. 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 PHYSICIAN AND PATIENT WERE INFORMED OF THE FAULTS AND THE POTENTIAL RISKS; HOWEVER, THE PATIENT IS CURRENTLY REFUSING TO COME TO THE HOSPITAL. THE PATIENT'S NEXT FOLLOW UP IS THE FIRST WEEK IN (B)(6) 2013 AND AT THAT TIME, A MEMORY DOWNLOAD WILL BE PERFORMED AND SENT TO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS. ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    CURRENTLY, THE DEIVCE REMAINS IMPLANTED AND IN SERVICE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ---

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT SIX MONTHS LATER, THE PATIENT EXPERIENCED A HEMODYNAMICALLY STABLE SUSTAINED VENTRICULAR TACHYCARDIA (VT). AFTER A FEW HOURS, THE DEVICE DID NOT DELIVER A SHOCK, AND THE PATIENT WENT TO THE HOSPITAL WHERE HE RECEIVED EXTERNAL CARDIOVERSION TO CONVERT THE ARRHYTHMIA. THE PATIENT THEN ASKED TO HAVE THE ICD REPLACED. DURING THE REVISION PROCEDURE, TELEMETRY COULD NOT BE ESTABLISHED WITH THE ICD AND NO TONES WERE HEARD WHEN A MAGNET WAS APPLIED. IT IS BELIEVED THAT THE BATTERY IS DEPLETED. THE DEVICE WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    A MEMORY DOWNLOAD WAS PERFORMED AND SENT IN TO BOSTON SCIENTIFIC FOR ANALYSIS. A COMPANY ENGINEER CONFIRMED THAT THE DEVICE BATTERY IS DEPLETING FASTER THAN EXPECTED. WITH THE CURRENT VOLTAGE AVAILABLE, THERAPY DELIVERY IS UNAFFECTED AT THIS TIME; HOWEVER, THE DATA INDICATES THAT THERE IS ENOUGH ENERGY FOR THE DEVICE TO MAINTAIN NORMAL FUNCTION FOR AN ADDITIONAL TWO WEEKS. AFTER THIS TIME, THERAPY DELIVERY CANNOT BE GUARANTEED. THIS INFORMATION WAS DISCUSSED WITH THE FIELD REPRESENTATIVE, AND IT WAS AGAIN STRESSED THAT THE DEVICE SHOULD BE REPLACED AND RETURNED FOR LABORATORY ANALYSIS AS SOON AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED A FAULT CODE AND A MESSAGE INDICATING THAT THE VOLTAGE IS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. DATA WAS REVIEWED FROM THE PATIENT'S REMOTE MONITORING SYSTEM AND THE TS CONSULTANT DISCUSSED THAT THE DEVICE'S BATTERY IS DEPLETING FASTER THAN EXPECTED. THERAPY IS NOT AFFECTED AS THE DEVICE BATTERY HAS A HIGH ENERGY RESERVE AT THIS TIME, BUT DUE TO THE DEPLETION RATE, DEVICE REPLACEMENT SHOULD BE CONSIDERED AS SOON AS POSSIBLE AS THERAPY MAY NOT BE GUARANTEED AFTER TWO WEEKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21057 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1