BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 2913155 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16538
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. THE SETSCREW WAS FOUND TO OPERATE APPROPRIATELY AND INSPECTION OF THE LEAD BARREL NOTED NO IRREGULARITIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. A LABORATORY TEST LEAD WAS INSERTED INTO THE HEADER OF THIS DEVICE. NO DIFFICULTIES WERE NOTED DURING INSERTION AND ALTHOUGH THE LEAD TIP DOES NOT APPEAR TO PROTRUDE VERY FAR INTO THE TERMINAL PIN PORTION OF THE LEAD BARREL, IT WAS CONFIRMED TO BE FULLY INSERTED. THE SETSCREW WAS FULLY TIGHTENED ON THE LEAD AND ELECTRICAL MEASUREMENTS WERE TAKEN. THE LEAD WAS MANIPULATED AND THE DEVICE CASE WAS TAPPED ON. THROUGHOUT THIS TESTING THE DEVICE PACED AND SENSED NORMALLY AND NO NOISE OR PAUSES IN PACING WERE NOTED. DEVICE MEMORY WAS REVIEWED AND IT WAS NOTED THAT LEAD IMPEDANCE TESTING WAS COMPLETED ON THE DATE OF IMPLANT AND RESULTED IN GOOD MEASUREMENTS. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE RESULTED IN INCOMPLETE LEAD INSERTION. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THIS DEVICE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD WAS TESTED WITH THE PACING SYSTEM ANALYZER (PSA) AND SATISFACTORY MEASUREMENTS WERE OBTAINED. THE TORQUE WRENCH WAS INSERTED INTO THE SEAL PLUG OF THIS DEVICE. THERE WAS CONCERN THAT THE LEAD TERMINAL PIN HAD NOT BEEN FULLY INSERTED AS THE PIN COULD BARELY BE VISUALIZED PAST THE CONNECTOR BLOCK DESPITE EFFORTS TO INSERT THE TERMINAL PIN. TO ASSURE THE CONNECTION WAS TIGHTENED SECURELY, THE TORQUE WRENCH WAS TURNED CLOCKWISE AND TURNED ADDITIONALLY. GENTLE TRACTION WAS APPLIED AND THE CONNECTION APPEARED SECURE. THE POCKET WAS CLOSED. FURTHER INTERROGATION WITH THE PSA REVEALED RIGHT VENTRICULAR HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE. THE PACEMAKER POCKET WAS REOPENED. GENTLE TRACTION WAS APPLIED AND THE LEAD CONNECTION APPEARED TIGHTENED. HOWEVER, THE TERMINAL PIN REMAINED BARELY VISIBLE BEYOND THE CONNECTOR BLOCK. THE SET SCREW WAS LOOSENED. THE LEAD PIN WAS PULLED BACK AND REINSERTED. HOWEVER THE TERMINAL PIN STOPPED AT THE SAME POSITION AND COULD NOT BE ADVANCED FURTHER. A DECISION WAS MADE TO REPLACE THE DEVICE TO ASSURE THERAPY AVAILABILITY. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19648 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J065

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R