BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1230567 · Received November 13, 2008

    Report

    Report Number
    2182207-2008-07441
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 10, 2008
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VASCULAR DAMAGE, NOT OTHERWISE SPECIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387-28, LOT# V098708, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULATURE WAS DAMAGED TUNNELING THE EXTENSION FROM THE HEAD TO THE CHEST WITH THE PASSER. THE HCP DISCOVERED THE BLEEDING IN THE MIDDLE OF THE OPERATION. THE PT WAS IN THE INTENSIVE CARE UNIT AFTER THE OPERATION WHERE HEMOSTATIC TREATMENT WAS PROVIDED. THE PT REMAINED HOSPITALIZED ONE MONTH AFTER IMPLANT SURGERY. THE DEVICE REMAINED IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A REPRESENTATIVE THAT DURING SURGERY, A PASSER WAS USED FOR TUNNELING THE EXTENSION FROM THE HEAD TO THE CHEST AND THE VASCULAR GOT DAMAGED. THE PATIENT WAS TAKEN INTO THE INTENSIVE CARE UNIT (ICU) AFTER THE OPERATION. THE PATIENT CONTINUED TO RECEIVE TREATMENT FROM A SURGERY PHYSICIAN. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY A MONTH LATER VIA THE REPRESENTATIVE REPORTED THE PHYSICIAN HAD FOUND THE PATIENT BLEEDING IN THE MIDDLE OF THE OPERATION. INTERVENTIONS INVOLVED HEMOSTATIC TREATMENT GIVEN TO THE PATIENT IN ICU. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS MOVED TO ANOTHER HOSPITAL AND CONTINUED TO BE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization EXPLANTED: