BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2791538 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14535
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE REMOVED. PATIENT REPORTED THAT THEIR "BODY REJECTED IT" THAT IT STARTED AS "OLD BLOOD" AND THEN THEIR SKIN SPLIT "DOWN BELOW" (NOT AT INCISION) AND COULD SEE CORNER OF DEVICE. FOLLOW-UP WITH THE CLINIC INDICATED THAT THE SYSTEM WAS REMOVED BUT THERE WAS NO CLEAR REASON AS TO WHY IT WAS REMOVED. IT WAS NOTED THAT THE PATIENT HAD HEMATOMAS AROUND THE DEVICE. THE SYSTEM HAS NOT BEEN 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
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R