BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN XL DR

    MDR report key: 3920727 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14327
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 1, 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 Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND A METALLIC PIECE INSIDE THE BATTERY BOOT SHUNTING THE BATTERY CATHODE TO CASE RESULTING IN PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION ON (B)(6) 2014, NOTED THAT THE DEVICE EXHIBITED PREMATURE ELECTIVE INDICATOR AGAIN DURING THE FOLLOW-UP. EXCESSIVE BATTERY DISCHARGE WAS SUSPECTED. THE DEVICE REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A PREMATURE ELECTIVE REPLACEMENT INDICATOR ONE MONTH POST-IMPLANT. THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION ON (B)(6) 2014, NOTED THAT THE DEVICE WAS EXPLANTED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396998 SUSTAIN XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2136 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention