BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 4160444 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02833
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. REFERENCED ARTICLE: SAFE PERFORMANCE OF MAGNETIC RESONANCE OF THE HEART IN PATIENTS WITH MAGNETIC RESONANCE CONDITIONAL PACEMAKER SYSTEMS: THE SAFETY ISSUE OF THE ESTIMATE STUDY. J. CARDIOVASC. MAGN. RESON. 2014;16(1):1097-6647. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THESE LEAD AND DEVICE MODELS. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/DEVICE SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: DECREASED ATRIAL AND VENTRICULAR SENSING INCREASED ATRIAL AND VENTRICULAR THRESHOLDS AND DECREASE IN DEVICE BATTERY VOLTAGE. THE STATUS OF THE LEADS AND DEVICES IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638334 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR 5086 LEAD IMPLANT UNK