BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE RV

    MDR report key: 3859389 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01597
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 1, 2003
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). POSSIBLE MODELS OF THE MEDTRONIC ICD DEVICE COULD INCLUDE: 7227, 7229, 7271, OR 7273. CORRESPONDENCE WAS SENT REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AT 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: ¿DETECTION AND MANAGEMENT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD FAILURE¿ JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. VOL. 41, NO.1. 2003; 73-80. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THE LEAD MODEL AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE OR LEAD SERIAL NUMBERS. MULTIPLE FAILURE MODES WERE REFERENCED IN THE ARTICLE, WITH NO SPECIFIC DEVICE OR LEAD MODEL FAILURE INDICATIONS. THE FAILURE MODES WERE NOTED AS: OVERSENSING/NOISE, HIGH PACING IMPEDANCE, HIGH SHOCKING IMPEDANCE, POOR SENSING OF R WAVES, LOW PACING IMPEDANCE, ABNORMAL IMPEDANCE, INFECTION, INAPPROPRIATE SHOCKS, INEFFECTIVE THERAPY, SHORT INTERVAL COUNTS, AND VARIABLE AND DECREASING IMPEDANCE. THE ARTICLE REPORTS THAT SOME LEADS WERE CAPPED, SOME WERE EXPLANTED AND REPLACED. ANALYSIS OF SOME LEADS SHOWED AN APPARENT FRACTURE AND INSULATION BREACH DUE TO METAL ION OXIDATION (MIO) OR ENVIRONMENTAL STRESS CRACKING (ESC). 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
    340660 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6936

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| L| R MDT-ICD