BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUSTAIN XL SRP

    MDR report key: 3923835 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14807
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARKERS WERE NOT ALIGNED WITH THE ELECTROGRAM. THE PATIENT EXPERIENCED SYNCOPE AND THE PHYSICIAN SUSPECTED A PULSE GENERATOR MALFUNCTION. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402003 SUSTAIN XL SRP IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1136 NA

    Patients

    Seq Age Sex Outcome Treatment
    1