BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2173644 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10849
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INTERROGATION OF THIS DEVICE IMPLANTED APPROXIMATELY FIVE YEARS DISPLAYED ELECTIVE REPLACEMENT NEAR (ERN) AND MAGNET RATE OF 90 PPM. A TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND PROVIDED A LONGEVITY ESTIMATE OF ONE YEAR REMAINING. IT WAS THOUGHT THAT ERN MAY HAVE BEEN REACHED EARLIER THAN EXPECTED, HOWEVER MAY HAVE BEEN IMPACTED BY PROGRAMMED PARAMETERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT PUERTO RICO BV 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR (B)(4)| (B)(4)| 1292| 0972