BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3251283 · Received July 29, 2013

    Report

    Report Number
    2182208-2013-01887
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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: D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD),  IMPLANTED: (B)(6) 2012; 693565 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2012; 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POCKET EROSION AND INFECTION OCCURRED. THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351938 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R