BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3951181 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14253
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    February 1, 2014
    Report Date
    October 22, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS CRT-D WAS THOROUGHLY INSPECTED AND ANALYZED. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE; HOWEVER, THE DIAMETER OF THE LV SPRING CONTACT COMPONENT WAS FOUND TO BE OUT-OF-SPECIFICATION. THIS MAY HAVE RESULTED IN A SUBOPTIMAL CONNECTION WITH THE LEAD TERMINAL. THIS LABORATORY FINDING MAY HAVE CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT WILL NOT BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THE POST MARKET QUALITY ASSURANCE LABORATORY WILL ANALYZE THE DEVICE WHEN IT IS RETURNED. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS. THERE WAS A GRADUAL INCREASE IN THE PACING IMPEDANCE MEASUREMENTS. NO OVERSENSING WAS NOTED DURING SUBSEQUENT IN CLINIC CHECK. THE DEVICE WAS REPROGRAMMED TO RV ONLY PACING. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS SCHEDULED FOR A LEAD EXTRACTION AS LEAD WAS SUSPECTED TO BE DISLODGED AFTER THE PATIENT HAD FALLEN OUT OF BED A FEW MONTHS PRIOR. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS CONTINUED TO BE OBSERVED. ADDITIONALLY, NO LV PACING WAS OBSERVED IN ANY PROGRAMMED CONFIGURATION. A LEAD FRACTURE WAS SUSPECTED, HOWEVER, WAS NOT CONFIRMED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS REPORTED THAT THE LEAD SUSTAINED DAMAGE DURING THE EXPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427528 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R H175| N118| 0157| 4518| 4472