BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3510978 · Received December 10, 2013

    Report

    Report Number
    2182208-2013-03706
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 16, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. A SPECIFIC COMPLAINT WAS NOT IDENTIFIED FOR ANY PARTICULAR MODEL. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF THE TIME OF THIS REPORT. 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 OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEADS UNDER ADVISORY - A COMPARISON OF RIATA, SPRINT FIDELIS, AND NON-RECALLED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEADS. HEART RHYTHM,.2013;10(10):1444-1450. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: CONDUCTOR FRACTURE, PAIN, LEAD PERFORATION, RETAINED LEAD FRAGMENTS AFTER OPEN HEART SURGERY, AND THE NEED FOR MAGNETIC RESONANCE IMAGING. THE LEADS WERE ALL EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642506 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-TACHY-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R