BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE RV

    MDR report key: 3992915 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02357
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: PRODUCT ID 4189 LEAD, IMPLANTED: (B)(6) 2001; PRODUCT ID 693352 LEAD, IMPLANTED: (B)(6) 1995, EXPLANTED: (B)(6) 2014; PRODUCT ID D224TRK ICD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD BEGAN TO SHOW INCREASED SHORT V-V COUNT AND NON-SUSTAINED TACHYCARDIA ELECTROGRAMS THAT SHOWED NOISE LASTING 1 SECOND IN DURATION. DUE TO THIS INCREASED NOISE, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD. HOWEVER, AT THE LEAD REPLACEMENT PROCEDURE, THE REPLACEMENT LEAD COULD NOT BE PASSED DOWN THE VESSEL DUE TO THE PATIENT¿S OCCLUDED VESSEL. SEVERAL WEEKS LATER, A NEW LEAD WAS SUCCESSFULLY PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468388 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 693675

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 4592-53 LEAD