BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY

    MDR report key: 2172825 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10142
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 27, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE INTERNAL ENVIRONMENT OF THIS DEVICE WAS TESTED AND A HIGHER THAN EXPECTED MOISTURE CONTENT WAS DISCOVERED. BOSTON SCIENTIFIC HAS ISSUED PHYSICIAN COMMUNICATIONS REGARDING GRADUAL DEGRADATION THAT MAY OCCUR IN A HERMETIC SEALING COMPONENT. THE DEGRADATION CAN ALLOW A HIGHER LEVEL OF MOISTURE INTO THE DEVICE CASE, WHICH MAY RESULT IN PREMATURE BATTERY DEPLETION, INAPPROPRIATE ACCELEROMETER FUNCTION, OR A RESET MESSAGE. THIS DEVICE IS INCLUDED IN THE JULY 18, 2005 HERMETIC SEALING COMPONENT ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A MAGNET RATE COULD NOT BE OBTAINED THROUGH TRANSTELEPHONIC MONITORING (TTM). AS A RESULT, THE PATIENT CAME TO THE OFFICE. AGAIN, A MAGNET RATE WAS NOT OBTAINED AND THE DEVICE COULD NOT BE INTERROGATED. SEVERAL DIFFERENT PROGRAMMERS WERE ATTEMPTED WITH DIFFERENT TROUBLE-SHOOTING TECHNIQUES. THE DEVICE WAS PROGRAMMED TO VVI 50, BUT WAS NOT PACING. THE LAST TTM WAS RECEIVED THREE MONTHS AGO WITH SUCCESSFUL MAGNET RATE AND PACING AT 100 BPM. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE NOTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1274

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening MISMATCH| (B)(4)| 4262| 1274