BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3994236 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10119
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    November 13, 2008
    Report Date
    November 20, 2008
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT DEVELOPED A WOUND INFECTION AT THE INCISION SITE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) HAD HIGH THRESHOLDS. A CHEST X-RAY SHOWED THE LEAD TO BE IN GOOD POSITION. THE DEVICE AND LEAD WERE EXPLANTED AND PATIENT WAS MONITORED IN THE HOSPITAL UNTIL THE INFECTION RESOLVED. A NEW PACING SYSTEM WAS IMPLANTED A MONTH LATER. THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466755 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R SESR01 IPG