BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3965002 · Received July 29, 2014

    Report

    Report Number
    2124215-2014-14634
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    May 10, 2014
    Report Date
    August 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 VIA THE PATIENT'S REMOTE MONITORING SYSTEM THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE OF LESS THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED AND DISCUSSED THAT THERE IS NO EVIDENCE OF NOISE ON PRESENTING OR STORED ELECTROGRAMS (EGMS) AND THE CHANGE IN IMPEDANCE IS NOT LARGE COMPARED TO RECENT HISTORY. ADDITIONAL INFORMATION INDICATED THAT A LEAD REVISION WAS PERFORMED. FURTHER, THE PHYSICIAN REPLACES THE RATE SENSE PORTION OF THE LEAD AND NO OBVIOUS BREACH WAS FOUND. THEREAFTER, SYNCHRONIZED SHOCK AND DEFIBRILLATION THRESHOLD (DFT) TEST WERE PERFORMED WITH ADEQUATE IMPEDANCE. MOREOVER, ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE WAS EXPLANTED AFTER THE PATIENT NEEDED T O HAVE A POCKET EVALUATION OF A HEMATOMA AND PHYSICIAN REQUESTED A NEW DEVICE. THE ICD WAS NO LONGER IN SERVICE, THE RV LEAD WAS PARTIALLY REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441517 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R E102| 0181| T175| MISMATCH| 0185