BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3093425 · Received May 6, 2013

    Report

    Report Number
    2182208-2013-01117
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    May 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4). A 8042B IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD): IMPLANTED: (B)(6) 2009. A 4965 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2005. A 4965 IMPLANTABLE PACING LEAD: IMPLANTED: 2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN APPARENT FRACTURE OF THE LEFT VENTRICULAR EPICARDIAL LEAD. IT WAS FURTHER REPORTED THE FRACTURE WAS SEEN ON CHEST XRAY. THE LEAD WAS REPLACED. THE LEAD WILL NOT BE RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196851 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Hospitalization| R