BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II

    MDR report key: 3082666 · Received April 29, 2013

    Report

    Report Number
    2124215-2013-07040
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 9, 2013
    Report Date
    September 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, TECHNICIANS USED AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    "THE HAS BEEN RETURNED FOR ANALYSIS."

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HEALTH CARE PROFESSIONAL (HCP) TAKING CARE OF THE PATIENT WITH THIS PACEMAKER THOUGHT THAT THE DEVICE DECLARED END OF LIFE (EOL) TOO QUICKLY. THE PATIENT HAD BEEN SEEN FOR A CLINIC VISIT IN (B)(6) 2012 AND THE DEVICE SHOWED <6 MONTHS REMAINING. SUBSEQUENTLY, THERE WAS A TRANSTELEPHONIC INTERROGATION IN (B)(6) 2013 WHERE THE DEVICE SHOWED THAT IT HAD DECLARED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS THEN DISCOVERED TO HAVE DECLARED EOL. THE PATIENT HAD COMPLAINED OF FATIGUE AND SHORTNESS OF BREATH FOR APPROXIMATELY ONE MONTH. THE PATIENT WAS SEEN FOR A CHANGE OUT PROCEDURE WHERE THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE IS TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185785 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1286

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 1286| 4034| 4063