BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 2780144 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12012
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    June 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. DETAILED ANALYSIS NOTED A MISSING RIGHT VENTRICULAR (RV) SET SCREW AND A LOOSE RV SEAL PLUG. THE RESULTS OF THE ANALYSIS CONFIRMED THAT THERE WAS VIRTUALLY NO MEDICAL ADHESIVE REMAINING ON THE SURFACE OF THE HEADER. THE PRIMARY FAILURE MODE IS ADHESIVE FAILURE (CLEAN SEPARATION) INDICATING POOR BOND STRENGTH BETWEEN THE MEDICAL ADHESIVE AND THE TECOTHANE HEADER. THE REASON FOR THE MISSING RV SET SCREW COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE LOOSE SEAL PLUG MAY HAVE CONTRIBUTED TO THE ALLEGATION FROM THE FIELD, HOWEVER, THIS CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, NOISE AND OVERSENSING WERE NOTED ON THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD. A HOLTER MONITOR WAS PROVIDED TO THE PATIENT AND IT REVEALED THE OVERSENSING RESULTED IN GREATER THAN TWO SECONDS OF ASYSTOLE. THE PACING IMPEDANCE MEASUREMENTS DROPPED ON BOTH LEADS. THE VENTRICULAR SENSITIVITY WAS PROGRAMMED TO 4MV STOPPED THE OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J063

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R