BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 4140470 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17599
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040/S306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL REPRESENTATIVE REPORTED THAT THE TERMINAL PIN WAS VISUALIZED FLUOROSCOPICALLY. IT APPEARED THAT THE TERMINAL PIN WAS NOT FULLY INSERTED BEYOND THE CONNECTOR BLOCK. THE TERMINAL PIN WAS REMOVED FROM THE HEADER AND MINERAL OIL WAS APPLIED OVER THE PIN. THE TERMINAL PIN WAS RE-INSERTED AND FLUOROSCOPIC IMAGING VERIFIED THAT THE TIP WAS NOW EXTENDED BEYOND THE CONNECTOR BLOCK. THE SET SCREW WAS TIGHTENED WITHOUT DIFFICULTY. ALL LEAD DIAGNOSTIC MEASUREMENTS WERE NORMAL AND NO FURTHER INTERVENTION WAS REQUIRED. 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 LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). ACCORDING TO THE LOCAL REPRESENTATIVE, THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULE REPLACEMENT OF A COMPETITOR DEVICE AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD. WHEN THE COMPETITOR REPLACEMENT DEVICE AND BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS CONNECTED, THE MEASURED R-WAVES WERE IN THE 2-3 MV RANGE. THE COMPETITOR DEVICE WAS REMOVED AND A BOSTON SCIENTIFIC DEVICE WAS CONNECTED. WHEN THE REPLACEMENT BOSTON SCIENTIFIC DEVICE AND RV DEFIBRILLATION LEAD WAS CONNECTED, THE R-WAVES IMPROVED; HOWEVER, A GREATER THAN 3000 OHM RV PACING AND GREATER THAN 200 RV SHOCK IMPEDANCE MEASUREMENTS WERE RECORDED. ADDITIONALLY, NOISE WAS PRESENT ON THE ELECTROGRAM. THE DEVICE HAD BEEN PROGRAMMED RV (COIL) TO CAN AND THE DEVICE WAS IN THE POCKET DURING LEAD DIAGNOSTIC TESTING. DESPITE RECONNECTING THE TERMINAL PIN OF THE RV DEFIBRILLATION LEAD MULTIPLE TIMES, OUT-OF-RANGE (OOR) RV PACING AND SHOCK IMPEDANCE MEASUREMENTS WERE RECORDED. THE PHYSICIAN REPORTED THAT THE TERMINAL PIN WAS INSERTED BEYOND THE CONNECTOR BLOCK AND THE WRENCH RATCHETED WHEN THE SET SCREW WAS TIGHTENED. THE PACING IMPEDANCE OF THE LEAD WHEN MEASURED THROUGH THE PSA WAS 700 OHMS. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619322 INOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D012

    Patients

    Seq Age Sex Outcome Treatment
    1 207 MO D012| MISMATCH| 0292| 5076