BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 7527786 · Received May 18, 2018

    Report

    Report Number
    3002648230-2018-00324
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    September 1, 2013
    Report Date
    May 18, 2018
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/MANUFACTURER SERIAL NUMBERS. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿SAFETY AND EFFICACY OF LONG-TERM RIGHT VENTRICULAR OUTFLOW TRACT SEPTAL PACING.¿ CHIN J GERIATR HEART BRIAN VESSEL DIS. SEPT 2013; VOL. 15, NO. 9. DOI: 10.3969/J.ISSN.1009-0126.2013.09.010. 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 LEADS. THERE WAS ONE ¿WIRE DISLOCATION.¿ THE LEAD WAS ¿SUCCESSFULLY¿ RE-IMPLANTED. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURERS/LEAD SERIAL NUMBERS. 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
    370542 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R