BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIB EPI PATCH

    MDR report key: 3993225 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02335
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 PRODUCTS: 4968-35 LEAD IMPLANTED: (B)(6) 2004 ; D154AWG ICD IMPLANTED: (B)(6) 2008; 6721M LEAD IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHANGE OUT PROCEDURE, THE RIGHT VENTRICULAR (RV) EPI LEAD WAS UNDERSENSING VENTRICULAR FIBRILLATION (VF) DURING INDUCTION. THE LEAD WAS CAPPED AND REPLACED. ADDITIONALLY, THE RV DEFIB EPI PATCH LEAD AND THE LEFT VENTRICULAR (LV) DEFIB EPI PATCH LEAD HAD HIGH DFTS (DEFIBRILLATION THRESHOLD TESTING). THEREFORE, THE RV DEFIB EPI PATCH LEAD WAS REMOVED FROM THE SVC PORT AND CONNECTED TO THE RV PORT AND HAD SUCCESSFUL DFTS. THE RV DEFIB EPI PATCH LEAD REMAINS IN USE. THUS, THE LV DEFIB EPI PATCH LEAD WAS REMOVED FROM THE RV HV (HIGH VOLTAGE) PORT AND MOVED INTO THE SVC PORT, BUT DID NOT END UP BEING PART OF THE DEFIB PATHWAY. THE LV DEFIB EPI PATCH LEAD ALSO REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470842 DEFIB EPI PATCH DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6721M

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Hospitalization| R 4968-35 LEAD