BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2240800 · Received September 1, 2011

    Report

    Report Number
    MW5022145
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 27, 2011
    Report Date
    September 1, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SUBJECT HAD DBS IMPLANTED ON (B)(6) 2011 FOR TARDIVE DYSKINESIA/DYSTONIA. PRESENTED TO ED ON (B)(6) WITH SEVERE L-SIDED EYE/FACIAL PAIN AND SWELLING AS WELL AS REDNESS AND SWELLING AT THE CORONAL INCISION SITE THAT ALL STARTED ON (B)(6). WAS DETERMINED TO HAVE CELLULITIS AFTER NEGATIVE CT HEAD AND LUMBAR PUNCTURE AND BEGAN TREATMENT WITH VANCOMYCIN WITH IMPROVEMENT. SHE WAS SWITCHED TO BACTRIM IN PREPARATION OF DISCHARGE ON (B)(6). PT AWOKE FROM SLEEP ON (B)(6) WITH SWOLLEN EYES AND A SEVERE, THROBBING HEADACHE AS WELL AS RETRO-ORBITAL PRESSURE WHICH WAS NEW. PT WAS PUT ON IV VANCOMYCIN AND CEFTAZIDIME. MRI BRAIN ON (B)(6) SHOWED NO INTRACRANIAL ABSCESS OR INFECTION. PT TO BE DISCHARGED ON IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA DEEP BRAIN STIMULATION MHY MEDTRONIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization