BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2984209 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00247
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 3, 2012
    Report Date
    March 12, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT A VARIATION IN SENSING AND PACING THRESHOLD WAS OBSERVED. THE NOISE WAS NOT REPRODUCED WITH PROVOCATIVE TESTING AND POCKET MANIPULATION. THE LEAD REMAINS IMPLANTED AND PATIENT WILL BE MONITORED. PATIENT MEDICAL CONDITION CONTINUES TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING DEVICE CHANGE OUT, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE NOTED. LEAD REMAINS IMPLANTED. PATIENT CONDITION AFTER THE EVENT WAS GOOD.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT WHEN THE DEVICE WAS INTERROGATED, A CAPTURE ANOMALY AND NOISE WERE OBSERVED. THE NOISE WAS UNABLE TO BE REPRODUCED IN REAL TIME. THE PHYSICIAN ELECTED NOT TO TAKE ANY ACTION. THE PATIENT CONDITION WAS GOOD.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PROGRAMMING CHANGES WERE MADE. THE PATIENT CONDITION WAS GOOD.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THE PACING THRESHOLD ON THE RIGHT VENTRICULAR CHANNEL WAS VARIABLE. ALL OTHER ELECTRICAL VALUES WERE STABLE AND IN RANGE. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86523 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1