BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3070758 · Received April 22, 2013

    Report

    Report Number
    2182208-2013-01104
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4). PRODUCT: E2SR01 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, WHO WAS NOTED TO BE PEDIATRIC, HAD BEEN SENT TO THE HOSPITAL SEVERAL TIMES BEFORE DUE TO "CONVULSION." RECENTLY, THE CLINIC CONFIRMED THAT THERE WAS A LEAD FRACTURE. IT WAS FURTHER NOTED THAT THERE WAS HIGH IMPEDANCE AND HIGH THRESHOLDS. THE LEAD REMAINS IN USE. ADDITIONAL INFORMATION OBTAINED NOTED THAT THE CAUSE OF THE "CONVULSIONS" IS UNKNOWN AND NO INFORMATION SUGGESTED IT WAS RELATED TO THE LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172920 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-50

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization