BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA ULTRA

    MDR report key: 922461 · Received September 28, 2007

    Report

    Report Number
    2124215-2007-99736
    Event Type
    Death
    Date Received
    September 28, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 25, 2007
    Manufacturer
    CLONMEL
    Product Code
    DXY
    Report Source
    Manufacturer report
    Reporter Location
    US

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THERE IS NO ADD'L INFO RELATED TO THIS EVENT AVAILABLE TO THE COMPANY AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, THE EVENT WILL BE UPDATED AS NECESSARY. ON JUNE 23, 2006, GUIDANT CORP (NOW BOSTON SCIENTIFIC CRM) ISSUED A PHYSICIAN COMMUNICATION REGARDING A WELL-DEFINED SUBSET OF DEVICES MANUFACTURED USING LOW-VOLTAGE CAPACITORS FROM A SINGLE COMPONENT SUPPLIER MAY PERFORM IN A MANNER THAT LEADS TO DEVICE MALFUNCTION, INCLUDING INTERMITTENT OR PERMANENT LOSS OF OUTPUT OR TELEMETRY, OR PREMATURE BATTERY DEPLETION. BOSTON SCIENTIFIC CRM DOES NOT HAVE SUFFICIENT INFO TO DETERMINE THAT THIS DEVICE BEHAVED IN THE MANNER DESCRIBED IN THE ADVISORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO FROM THE PATIENT'S WIFE IN A LETTER THAT HER HUSBAND PASSED AWAY DUE TO OUR DEVICE MALFUNCTIONING. THE LETTER DID NOT PROVIDE A DATE OF DEATH AND BOSTON SCIENTIFIC CRM HAS BEEN UNABLE TO CONFIRM THE DATE OF DEATH. IN THE LETTER, THE WIFE CLAIMS THAT THIS PACEMAKER WAS INCLUDED WITHIN A SUBSET OF DEVICES AFFECTED BY A PHYSICIAN COMMUNICATION REGARDING THE LOW VOLTAGE CAPACITOR (2006). SHE ASSERTS THAT SHE AND HER HUSBAND HAD REQUESTED THAT THE PACEMAKER BE REMOVED AND REPLACED SHORTLY AFTER NOTIFICATION OF THE ADVISORY, BUT WERE REFUSED. IN THE LETTER, THE WIFE ALSO ASSERTS THAT IN A CONVERSATION WITH A GUIDANT FIELD REP, THE PHYSICIAN HAD SAID NOT TO WORRY ABOUT IT. SHE BLAMES OUR COMPANY 100% FOR HER HUSBAND'S DEATH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ULTRA IMPLANTABLE PULSE GENERATOR DXY CLONMEL 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 4087| 4088