BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN XL SRP

    MDR report key: 3920689 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14295
    Event Type
    Injury
    Date Received
    July 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS INJURED BUT NO INTERVENTION HAD BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE; THE PATIENT FELL AND BROKE HIS SHOULDER. UPON INTERROGATION THE PULSE GENERATOR EXHIBITED OVERSENSING. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396891 SUSTAIN XL SRP IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1136 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other