BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3904185 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-07995
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0088-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED LOW VOLTAGE ALERTS (CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. AFTER THE TITANIUM CASE WAS OPENED, 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 NOT A PART OF THE IDENTIFIED POPULATION.

    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 NOT INCLUDED IN THE (B)(4) 2013 ADVISORY POPULATION, BUT WAS ADDED TO THE EXPANDED POPULATION ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REPLACEMENT PROCEDURE WILL BE SCHEDULED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HEARD BEEPING TONES BEING EMITTED FROM THE DEVICE. THE PATIENT DID AN INTERROGATION WITH THEIR REMOTE MONITORING DEVICE AND IT DISPLAYED A LOW VOLTAGE WARNING MESSAGE. THE PATIENT WENT TO THE HOSPITAL AND IT WAS CONFIRMED THAT THIS ICD RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DISK ANALYSIS SHOWED THE BATTERY APPEARS TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND IS EXPECTED TO BE RETURNED FOR A POST-MARKET ANALYSIS. NO RESULTING ADVERSE PATIENT EFFECTSS WERE REPORTED AND ANOTHER BOSTON SCIENTIFIC DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382272 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 0185| E102