BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 8378421 · Received February 28, 2019

    Report

    Report Number
    2182208-2019-00389
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS. POSSIBLE MODELS COULD INCLUDE: 4298, 4398, 4598. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 69 YEARS OLD. 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. NO FURTHER INFORMATION IS AVAILABLE. REFERENCED ARTICLE: OUTCOMES OF CARDIAC RESYNCHRONIZATION THERAPY USING LEFT VENTRICULAR QUADRIPOLAR LEADS. PACING CLIN ELECTROPHYSIOL. 2018;41:912¿919. HTTPS://DOI.ORG/10.1111/PACE.13388. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE LEFT VENTRICULAR (LV) PACING LEADS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WITH LEAD DISLODGEMENTS, REPORTS OF NON-CAPTURE, ¿ANODAL¿ STIMULATION, AND PHRENIC NERVE STIMULATION (PNS). THE TREATMENT/RESOLUTIONS WERE THAT THE LEADS WERE REPROGRAMMED, LEAD REVISIONS, AND/OR THE LEADS WERE TURNED OFF OR ABANDONED. THE STATUS/LOCATION OF THE LEAD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172264 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)