BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 1572702 · Received January 8, 2010

    Report

    Report Number
    2017865-2010-00029
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    October 19, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR WAS IN BACK-UP MODE. BATTERY DEPLETION ALSO OCCURRED DUE TO A HIGH CURRENT DRAIN WHICH WAS CAUSED BY A LEAKY CAPACITOR. AFTER REPLACING THE CAPACITOR, NORMAL FUNCTION ENSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A HIGH BATTERY CURRENT DRAIN OF 72 UA AT FOLLOW-UP. AFTER A FIRM- WARE DOWNLOAD, BATTERY MEASUREMENTS STILL PRESENTED A HIGH CURRENT DRAIN. THE DEVICE IMAGE REVEALED THAT THE CURRENT DRAIN ROSE FROM 7 TO 81 UA OVER A PERIOD OF TWO MONTHS. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING FEELING OVERFILLED IN DWELL 1 ON THE HOMECHOICE(HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PROGRAMMING: THE HOME PATIENT (HP) PERFORMS CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) WITH A MIDDAY EXCHANGE OF 2500ML AND CONTINUOUS CYCLING PERITONEAL DIALYSIS, WITH A FILL VOLUME (FV) OF 2200ML AND A LAST FILL VOLUME (LFV) OF 500ML. THE INITIAL DRAIN ALARM (IDA) IS 200ML. THE HP HAD AN INITIAL DRAIN VOLUME OF 372ML. THE TSR HAD THE HP DO A MANUAL DRAIN AND DRAINED OUT 4802ML. THE DRAIN VOLUME OF 4802ML MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE TSR ADVISED HP TO CONTACT PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) AND PROGRAM AN APPROPRIATE IDA BEFORE USING HC AGAIN. HP RESUMED THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5816 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention