BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 4829994 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01830
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 1, 2015
    Report Date
    April 13, 2015
    Manufacturer
    MEDTRONIC PLC
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE AGE/GENDER IS (B)(6) YEARS OLD AND MALE. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. POSSIBLE MODELS COULD INCLUDE: 6930; 6931; 6948; 6949. THESE LEAD MODELS ARE PART OF A FIELD ACTION. 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: TRANSVENOUS EXTRACTION PROFILE OF RIATA LEADS: PROCEDURAL OUTCOMES AND TECHNICAL COMPLEXITY OF MECHANICAL REMOVAL. HEART RHYTHM. 2015;12(3):580-587. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE LEADS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE REPORTS OF INFECTION/SEPSIS/MALFUNCTION, REMOVAL FAILURE, EXTRACTION DIFFICULTIES, ¿FIBROUS ADHERENCES,¿ AND TWO MINOR COMPLICATIONS. ALL LEADS APPEAR TO HAVE BEEN EXTRACTED. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375704 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC PLC MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention