BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUBY III DDD

    MDR report key: 3990180 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02261
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO FEELING UNCOMFORTABLE WITH HEART. IT WAS NOTED THE PATIENT FELT WEAKNESS AND TIGHTNESS IN THE CHEST. ELECTROCARDIOGRAM (ECG) AND PROGRAMMING CHECK DETERMINED DEVICE BATTERY DEPLETION. HOWEVER, THE PHYSICIAN REPORTED AS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463429 RUBY III DDD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG RB740U

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R