BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILD DEVICE KIT

    MDR report key: 3104831 · Received May 7, 2013

    Report

    Report Number
    3006450448-2013-00001
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 6, 2013
    Manufacturer
    VERTOS MEDICAL INC
    Product Code
    HRX
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF CHRONIC BACK PAIN UNDERWENT A BILATERAL LUMBAR DECOMPRESSION AT L3-L4 LEVEL UNDER MONITORED ANESTHESIA. THE PT HAD A PAIN PUMP PREVIOUSLY IMPLANTED AND THE CATHETER WAS LOCATED AT A LEVEL ABOVE THE TREATMENT SITE. NEAR THE CONCLUSION OF THE PROCEDURE, IT WAS DISCOVERED THAT A PIECE OF CATHETER FROM THE PT'S PAIN PUMP HAD BEEN RETRIEVED. THE PROCEDURE WAS CONCLUDED AND THE PT WAS DISCHARGED. THE PT UNDERWENT A PUMP REVISION ON THE EVENING OF (B)(6) 2013, AND IS DOING WELL WITH NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199641 MILD DEVICE KIT HRX, HAE HRX VERTOS MEDICAL INC MDK-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention