BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3232018 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11235
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    August 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR CURRENT INVESTIGATION IS COMPLETE AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS ICD WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT FAULT CODE 1003 WAS RECORDED ON (B)(6) 2013. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT (3.69 VOLTS) WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    APPROXIMATELY THREE WEEKS LATER, IT WAS CONFIRMED THAT THE DATA DISK OF THIS DEVICE HAD BEEN DAMAGED IN SHIPMENT. HOWEVER, A BOSTON SCIENTIFIC ENGINEER WAS ABLE TO RETRIEVE THE REMOTE MONITORING MEMORY DOWNLOAD DATA. REVIEW OF THIS DATA CONFIRMED THE LOW VOLTAGE FAULT MALFUNCTION, WITHOUT ANY OTHER ANOMALIES IN MEMORY OR RESET OCCURRENCE. ADDITIONALLY, THE DEVICE HARDWARE DID NOT DETECT ANY LOSS OF BATTERY ENERGY, AND THERAPY DELIVERY REMAINS UNAFFECTED WITH THIS ANOMALY. BATTERY BEHAVIOR APPEARS INTERMITTENT OVERTIME, AND MAY CHANGE UNPREDICTABLY. ENGINEERING CONFIRMED THAT THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND THUS ARE INACCURATE; THEY SHOULD NO LONGER BE RELIED UPON TO DETERMINE DEPLETION STATUS OF THE DEVICE. THE DATA INDICATES WITH A VERY HIGH LIKELIHOOD THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE MAINTAIN NORMAL THERAPY FUNCTIONS FOR 14 DAYS' TIME. AS THE DEVICE HAS A CONFIRMED MALFUNCTION, IT IS RECOMMENDED TO EXPLANT AND REPLACE THIS DEVICE FOR FURTHER ANALYSIS. CURRENTLY THE DEVICE REMAINS IMPLANTED, AND THERE ARE NO REPORTED ADVERSE EFFECTS FROM THE PATIENT.

    Description of Event or Problem · 1

    SUBSEQUENTLY ONE WEEK LATER, THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING INTERROGATION, AN ALERT WAS RECEIVED NOTING VOLTAGE TOO LOW FOR REMAINING CAPACITY. HOWEVER, THE LONGEVITY PARAMETERS REMAINED WELL OVER NINE YEARS. BOSTON SCIENTIFIC TECHNICAL THERAPY SERVICES RECOMMENDED PATIENT RETURN TO PERFORM A MEMORY DOWNLOAD, AND SAVE THE INFORMATION TO DISK FOR FURTHER ANALYSIS AND RECOMMENDATIONS. NO CURRENT ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330934 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R