BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILD DEVICE KIT

    MDR report key: 3129824 · Received May 21, 2013

    Report

    Report Number
    3006450448-2013-00002
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    August 22, 2012
    Report Date
    May 21, 2013
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(6) MALE PT WITH DIAGNOSED SEVERE STENOSIS AND NEUROPATHY UNDERWENT A MINIMALLY INVASIVE LUMBAR DECOMPRESSION (MILD) PROCEDURE ON (B)(6) 2012. THE PATIENT STATED THAT "SOMETHING HAPPENED ON THE OPERATING ROOM TABLE THAT NOT ONLY LEFT HIM WITH THE STENOSIS BUT ALSO WITH DROP FOOT". PT STATED THAT ON (B)(6) 2012, HE "RETURNED TO THE HOSPITAL, HAD ZERO CONTROL OF MY LEGS ALONG WITH OTHER PROBLEMS". ACCORDING TO THE PT, AN MRI WAS PERFORMED AND "WAS TOLD AREA OF SPINAL COLUMN WAS INFLAMED". THE PT STATED HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 AND WAS TOLD THAT THE "FOOT DROP" CONDITION IN HIS RIGHT FOOT WOULD BE GONE IN 3 MONTHS. ACCORDING TO THE PT, HE HAD BEEN TOLD THAT HE STILL HAD STENOSIS, AND THAT AS A RESULT OF EMG TESTING (PERFORMED IN 2010), THE NERVES IN THE RIGHT LEG ARE SEVERELY DAMAGED. PT STATED THAT BECAUSE OF HIS AGE AND THE FACT THAT HE WAS A DIABETIC, HE WILL PROBABLY HAVE FOOT DROP FOREVER. ACCORDING TO THE PHYSICIAN WHO PERFORMED THE MILD PROCEDURE, THE PT HAD SEVERE STENOSIS AND WAS ADVISED THAT HE SHOULD HAVE OPEN SURGERY, BUT THE PT INSISTED THAT THE MILD PROCEDURE BE TRIED FIRST. ACCORDING TO THE PHYSICIAN, AFTER THE MILD PROCEDURE, THE PT HAD A LITTLE "TOE WEAKNESS" AND FELL AT HOME. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE THE DEVICE WAS THE CAUSE AND THAT THE PT'S CONDITION COULD BE A POSSIBLE COMPLICATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225459 MILD DEVICE KIT HRX, HAE HRX VERTOS MEDICAL INC. MDK-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| S