BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2042485 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01336
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. 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) RECORDED OUT OF RANGE RIGHT VENTRICULAR (RV) IMPEDANCES OF GREATER THAN 2,000 OHMS. THERE WAS ONE EPISODE OF NOISE NOTED ON THE RV CHANNEL. IT WAS NOTED THAT WHILE PERFORMING PATIENT ISOMETRICS, IMPEDANCES WERE GREATER THAN 2,000 OHMS AND NOISE WAS OBSERVED ON THE SHOCK CHANNEL. SENSING MEASUREMENTS HAD ALSO NOTED TO HAVE DECREASED. TECHNICAL SERVICES (TS) DISCUSSED A LEAD ISSUE WAS LIKELY AND RECOMMENDED DISCUSSING FURTHER WITH THE PHYSICIAN. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION IN THE NEXT WEEK. THE DEVICE WAS PROGRAMMED TO VVI UNTIL THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE RATE/SENSE PORTION OF THIS PATIENT'S DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED, AND A NEW RV PACE/SENSE LEAD WAS IMPLANTED. ALSO DURING THE PROCEDURE, LOW SHOCK IMPEDANCES OF LESS THAN 20 OHMS, AS WELL AS NOISE, WERE OBSERVED. TS DISCUSSED POSSIBLE SOURCES OF ELECTRO MAGNETIC INTERFERENCE IN THE ROOM. ONCE EXTERNAL EQUIPMENT WAS TURNED OFF, THE ISSUES WERE RESOLVED. NO ISSUES HAVE BEEN NOTED SINCE THE PROCEDURE. THE PATIENT HAD ALSO NOTED THAT APPROXIMATELY ONE MONTH AGO, THEY HAD FALLEN INTO A CORNER CABINET, HITTING THEIR DEVICE AREA. THE PHYSICIAN SUSPECTED THIS FALL HAD DAMAGED THE LEAD; ALTHOUGH IT WAS REPORTED THAT NO FRACTURE WAS VISIBLE VIA FLUOROSCOPY DURING THE PROCEDURE. 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 56 YR Required Intervention E110| 0184| A155| 4470