BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2060166 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06221
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    June 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, IT WAS NOTED THE DISTAL RV SETSCREW HAD NOT BEEN SEATED. PROPER CONNECTION WAS REESTABLISHED AND THE PROBLEM WAS RESOLVED. NO FURTHER PATIENT EFFECTS WERE REPORTED. 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, THE DEVICE WAS ANALYZED. VISUAL INSPECTION NOTED BODY FLUID CONTAMINATION IN THE LEAD PORT BARRELS. A HOLE IN THE DISTAL ATRIAL SEAL PLUG WAS ALSO OBSERVED. THE REPORTED HOLE IN A VENTRICULAR SEAL PLUG WAS NOT CONFIRMED. INSPECTION OF THE SEAL PLUGS CONCLUDED THE HOLE WAS LIKELY INDUCED. 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. ANALYSIS CONCLUDED THE REPORTED OBSERVATIONS WERE MOST LIKELY DUE TO THE LEAD IMPLANTED WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAD BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT HAD PRESENTED WITH AN IRREGULAR RHYTHM DUE TO LOSS OF CAPTURE. THE PACING IMPEDANCE MEASUREMENT WAS GREATER THAN 2500 OHMS IN BIPOLAR PACING MODE. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT, DAMAGE TO A VENTRICULAR SEAL PLUG WAS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE HAD REPORTED SLOW HEART RATES OF APPROXIMATELY 40 BEATS PER MINUTE (BPM). A HOLTER MONITOR RECORDED SEVERAL PAUSES IN PACING. INTERROGATION OF THE DEVICE NOTED OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, CAUSING PACING INHIBITION. THE PATIENT HAD AN ESCAPE RHYTHM OF ABOUT 40 BPM. THE DEVICE SENSITIVITY WAS REPROGRAMMED TO ENSURE CONSTANT PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention