BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4193604 · Received October 22, 2014

    Report

    Report Number
    2182208-2014-03115
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 22, 2014
    Manufacturer
    RICE CREEK MFG.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: TRANSIENT VARIATIONS OF TRANSTHORACIC IMPEDANCE AS A PREDICTOR OF HEART FAILURE AND DEATH IN PATIENTS WITH IMPLANTED DEFIBRILLATORS. INTERNATIONAL JOURNAL OF CARDIOLOGY. 2014;175(3):473-477. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE MODEL. MULTIPLE PATIENTS AND MULTIPLE DEATHS AND INAPPROPRIATE SHOCKS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672469 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS RICE CREEK MFG. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death