BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2052144 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03663
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED, THE LEAD WAS TESTED AND MEASUREMENTS WERE REPORTED AS NORMAL. TECHNICAL SERVICES DISCUSSED PHYSICIAN DISCRETION IN DETERMINING LEAD INTEGRITY. THE DEVICE WAS BEING RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A REVIEW OF THE MEMORY LOG FOUND THAT ON THE DATE OF IMPLANT, (B)(6) 2010, THE DEVICE HAD RECORDED A SHORTED LEAD FAULT. THE SHORTED LEAD FAULT WAS ACKNOWLEDGED PRIOR TO THE DEVICE DECLARING EOL. VISUAL INSPECTION OF THE ICD IDENTIFIED NO ANOMALIES. AN X-RAY OF THE INTERNAL CIRCUITRY FOUND AN INTERNAL FUSE WAS DAMAGED, CONSISTENT WITH DAMAGE CAUSED BY A SHORTED CONDITION DURING SHOCK DELIVERY. EXTERNAL SHORTING OF THE LEAD(S) DURING A CHARGE IS KNOWN TO CAUSE INTERNAL DAMAGE AND DEVICES ARE NOT EXPECTED TO PERFORM TO SPECIFICATION POST SHORTED LEAD EVENTS. LABORATORY ANALYSIS CONCLUDED THE DEVICE REACHED EOL DUE TO EXTERNAL SHORTING OF THE LEADS WHICH CAUSED DAMAGE TO THE INTERNAL FUSE. IN ADDITION, THE N/R VALUES WERE A RESULT OF THE SUBSEQUENT EPISODES WITH A CHARGE TIME OUT FAULT.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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) HAD DECLARED END OF LIFE AFTER THREE MONTHS OF IMPLANT. THE LAST RECORDED CHARGE TIME WAS 45 SECONDS. A MANUAL CAPACITOR REFORMATION ALSO PROVIDED 45 SECOND CHARGE TIMES. THERE WAS INQUIRY AS TO WHY N/R WAS SEEN FOR LAST DELIVERED SHOCK. TECHNICAL SERVICES (TS) DISCUSSED DECLARATION OF EOL AND POSSIBLE CAUSES. TS ALSO ADVISED THE DEVICE BE REPLACED AS THERAPY CAN NOT BE DELIVERED. A SAVE TO DISK WAS ALSO RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention E110| 4461| 0041| MISMATCH| 4470| 4320| A155| 0145| 1600| 1851