BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC LEAD

    MDR report key: 4877618 · Received June 30, 2015

    Report

    Report Number
    2182208-2015-02206
    Event Type
    Death
    Date Received
    June 30, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-2008-6931
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE LEADS INVOLVED IN THIS EVENT ARE PART OF A NOTIFICATION/RECALL AND THE NOTIFICATION NUMBER INDICATED IS PART OF THE SAME LEAD MODEL FAMILY; WITH ONE OF THE CORRECTION NUMBERS BEING: Z-0067-2008-6931. POSSIBLE LEAD MODELS REFERENCED IN THE ARTICLE COULD INCLUDE: 6930, 6931, 6948, AND 6949. 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: FACTORS PREDICTING SPRINT FIDELIS LEAD FRACTURE: RESULTS AT 5 YEARS FROM A (B)(6) MULTICENTRE REGISTRY. ARCHIVES OF CARDIOVASCULAR DISEASES. 2015;108(4):220-226. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE TACHY 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 REPORTS THAT THERE WERE PATIENT DEATHS, INAPPROPRIATE SHOCKS EXPERIENCED BY PATIENTS, AS WELL AS APPARENT FRACTURES, IMPEDANCE RISES, ¿ABRUPT¿ DECREASES IN RIGHT VENTRICULAR SENSING, OVERSENSING, SHORT INTERVAL COUNTS (SIC), AND NON-SUSTAINED VENTRICULAR FIBRILLATION EPISODES. THE STATUS OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF DEATH AND DEVICE AND MANUFACTURER/RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421460 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death| L| R ICD