BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3212584 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09512
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. VISUAL AND MECHANICAL INSPECTION OF THE SET SCREWS WAS PERFORMED, AND THEY MOVED NORMALLY AND COMPLETELY IN BOTH CLOCKWISE AND COUNTER-CLOCKWISE DIRECTIONS. THE LEAD BARRELS HAD NO IRREGULARITIES. 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 PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE FIELD OBSERVATION WAS NOT ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A GENERATOR CHANGE-OUT DUE TO NORMAL BATTERY DEPLETION. THIS PACEMAKER REPLACED THE PATIENT¿S OLD DEVICE, AND THE CHRONIC RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS REMAINED IN SERVICE. DURING RECOVERY, THE PATIENT SAT UP AND THERE APPEARED TO BE LOSS OF CAPTURE AND THE PATIENT WAS SYMPTOMATIC. A REVISION PROCEDURE WAS PERFORMED AND ALL MEASUREMENTS THROUGH THE DEVICE AND PACING SYSTEM ANALYZER (PSA) WERE OKAY. THE LEADS WERE RECONNECTED AGAIN, AND IT WAS SUSPECTED THAT THE LEAD HAD BEEN LOOSE IN THE HEADER WITH A SET SCREW ISSUE. APPROXIMATELY, NINETY MINUTES AFTER THE REVISION PROCEDURE THE PATIENT SAT UP AND THERE APPEARED TO BE LOSS OF CAPTURE AGAIN, AS WELL AS, OVERSENSING AND PACING INHIBITION. ISOMETRIC TESTING WAS DONE AND NO NOISE OR OVERSENSING WAS REPRODUCED. THE FIELD REPRESENTATIVE TESTED THE DEVICE AND REPRODUCED THE OBSERVATION WHEN THE PATIENT SAT UP, AND THE ISSUE RESOLVED WHEN THE PATIENT LAID DOWN. THERE WAS NO ASYSTOLE GREATER THAN TWO SECONDS NOTED. NO FURTHER TESTING WAS PERFORMED AS THE HEALTH CARE PROFESSIONAL (HCP) STOPPED THE EVALUATION AND SCHEDULED ANOTHER REVISION. SURGICAL INTERVENTION WAS AGAIN PERFORMED AND THIS DEVICE WAS EXPLANTED AND THE CHRONIC RA AND RV LEADS WERE CAPPED AS LEFT-SIDED ACCESS WAS NOT ABLE TO BE OBTAINED. A NEW PACING SYSTEM WAS IMPLANTED ON THE PATIENT¿S RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313388 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4034| 1296| 4136| 4053| K063| 1270| 4135