BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3991077 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02188
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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: PAROXYSMAL ATRIAL FIBRILLATION OCCURS OFTEN IN CRYPTOGENIC ISCHAEMIC STROKE. FINAL RESULTS FROM THE SURPRISE STUDY. EUR. J. NEUROL. 2014;21(6):884-889. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE LOOP RECORDER (ILR). MULTIPLE PATIENTS WITH MULTIPLE FAILURE MODES AND ADVERSE EVENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: LACK OF DEVICE DETECTION, DEVICE UNDERSENSING. THREE ILR¿S WERE REMOVED DUE TO SKIN REACTION AND DISCOMFORT FROM THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468210 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R