BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3041112 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00886
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 28, 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

    FOLLOWING PRODUCT RETURN AND COMPLETION OF LAB ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE COULD NOT BE INTERROGATED AND MEMORY COULD NOT BE EXTRACTED FROM THE DEVICE. ADDITIONALLY, THE DEVICE EXHIBITED NO PACING OUTPUT. THE DEVICE CASE WAS OPENED AND THE MIXED MODE INTEGRATED CIRCUIT (MMIC) WAS ISOLATED. HIGH POWERED VISUAL INSPECTION REVEALED DAMAGE TO THE SURFACE OF THE MMIC AND ELECTRICAL RUNS. THE LOCATION OF THE DAMAGE WAS IN A PORTION OF THE CIRCUITRY THAT CONTROLLED THE PACING OUTPUT FOR THE DEVICE. FINAL ANALYSIS CONCLUDED THIS DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS. SEVERAL CORRECTIVE ACTIONS STEPS, INCLUDING AUTOMATED AS WELL AS MANUAL PROCESSES, HAVE BEEN IMPLEMENTED TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SUFFERED A PRE-SYNCOPAL EPISODE AT HOME AND SOUGHT MEDICAL ATTENTION. DURING INTERROGATION, IT WAS NOT POSSIBLE TO COMMUNICATE WITH THE DEVICE. AN ELECTROGRAM SHOWED THIRD DEGREE AV BLOCK WITH NO PACING SPIKES; THE PATIENT EXHIBITED AN ESCAPE RHYTHM OF 35 BPM. A FEW DAYS LATER THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON BOSTON SCIENTIFIC PRODUCT WITHOUT COMPLICATIONS AND THE PATIENT DISMISSED. THE EXPLANTED UNIT IS INTENDED TO BE RETURNED FOR A POST MARKET EVALUATION. IT WAS ADDITIONALLY REPORTED THAT DURING THE MOST RECENT CLINICAL FOLLOW-UP, APPROXIMATELY 10 DAYS PRIOR TO THE DATE OF THE REPORTED INCIDENT, THIS DEVICE EXHIBITED A MAGNET RATE OF 100/MIN, WITH AN ESTIMATED LONGEVITY OF 4.5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143002 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R