BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 4638524 · Received March 27, 2015

    Report

    Report Number
    2182208-2015-00782
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 4, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE AGE IS 20 YEARS OLD. THE PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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. REFERENCED ARTICLE: CARDIAC IMPLANTABLE ELECTRONIC DEVICE REMOTE MONITORING SURVEILLANCE IN PEDIATRIC AND CONGENITAL HEART DISEASE: UTILITY RELATIVE TO FREQUENCY. HEART RHYTHM. 2015;12(1):117-122. CONCOMITANT PRODUCT: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), IMPLANTABLE PULSE GENERATORS (IPG), AND IMPLANTABLE LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REFERENCED THE FOLLOWING COMPLICATIONS/FAILURE MODES: ARRHYTHMIAS, LEAD/DEVICE ¿MALFUNCTION,¿ LEAD FRACTURES, SHOCKS, POLARITY CHANGES, PERFORATION, DISLODGEMENT, ¿FALSE POSITIVE¿ LEAD ISSUE. MEDICAL AND/OR SURGICAL INTERVENTION WAS DONE WHICH INCLUDED, BUT WAS NOT LIMITED TO, REPROGRAMMING, REVISION, EXPLANT PROCEDURE, OUTPUT ADJUSTMENTS, AND MEDICATION CHANGES. THE STATUSES OF THE DEVICES/LEADS ARE UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206406 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Hospitalization| L| R IMPLANTABLE LEAD