BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992231 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09982
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    December 3, 2013
    Report Date
    June 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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 PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY FELT SHOCKS FROM THEIR PACEMAKER, AND THAT THEY WERE ADMITTED TO THE HOSPITAL FOR CHEST PAIN AND FATIGUE. IT WAS FURTHER REPORTED BY THE PATIENT THAT AN ECHOCARDIOGRAM WAS DONE WHICH FOUND A PERFORATION FROM THE VENTRICLE LEAD. ACCORDING TO THE PATIENT, THE VENTRICLE LEAD WAS REPOSITIONED, BUT THEY CONTINUE TO FEEL SHOCKS FROM THE DEVICE. THE PACEMAKER HAS BEEN CHECKED BY A DOCTOR AND DETERMINED TO BE FUNCTIONING NORMALLY. NO FOLLOW-UP INFORMATION COULD BE OBTAINED FROM THE CLINIC. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469375 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R ADDRL1 IPG