BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN TEMPORARY LEAD

    MDR report key: 6924124 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01672
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    May 1, 2003
    Report Date
    August 1, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LDF
    PMA / PMN Number
    K973360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿UTILITY AND SAFETY OF PROLONGED TEMPORARY TRANSVENOUS PACING USING AN ACTIVE-FIXATION LEAD: COMPARISON WITH A CONVENTIONAL LEAD.¿ PACE 2003; 26:1245¿1248.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS TEMPORARY PACING LEAD MODEL. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WITH INFECTION, VENOUS THROMBOSIS ¿INAPPROPRIATE SENSING,¿ AND DISLOCATIONS. 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
    699631 SCREW-IN TEMPORARY LEAD ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC, INC. 6416

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R