BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD, UNKNOWN

    MDR report key: 3354809 · Received September 18, 2013

    Report

    Report Number
    3007566237-2013-03052
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD NOT EASILY TREATED HIGH BLOOD PRESSURE (200/130) RESULTING IN AN ABORTED IMPLANT PROCEDURE. IT WAS NOTED THE IMPLANT PROCEDURE WAS POSTPONED UNTIL (B)(6) 2013. IT WAS FURTHER NOTED THE PATIENT¿S LAB RESULTS WERE ELEVATED HGB, RBC, MCH, LYYMPAB, AND GLUC. ON (B)(6) 2013. IT WAS NOTED THE PATIENT¿S LAB RESULTS ON (B)(6) 2013 WERE ELEVATED MCH, NEUTRE, LYMPRE, LYMPAB, AND GLUC. IT WAS NOTED THE PATIENT¿S LAB RESULTS ON (B)(6) 2013 WERE ELEVATED MCH, LYMPRE, LYMPAB, CL, AND GLUC. IT WAS FURTHER NOTED THE PATIENT HAD A CT SCAN WITHOUT CONTRAST ON (B)(6) 2013 AND THEY HAD A PNEUMOCEPHALUS OVER THE RIGHT CEREBRAL HEMISPHERE AS WELL AS PATCHY SCALP AIR WITH DIFFUSE SCALP SWELLING. IT WAS NOTED THE PATIENT HAD A SECOND CT SCAN ON (B)(6) 2013 AND THERE WAS LITTLE INTERVAL CHANGE FROM THE SCAN DONE EARLIER IN THE DAY. IT WAS NOTED THAT THE PATIENT HAD AND ELECTROENCEPHALOGRAM (EEG) ON (B)(6) 2013 AND THE RESULTS WERE ABNORMAL EEG BECAUSE OF CONTINUOUS GENERALIZE SLOW ACTIVITY AND ¿SLOW PDR.¿ IT WAS NOTED THE PATIENT¿S LAB RESULTS FOR (B)(6) 2013 WERE ELEVATED GLUBED, HGB, PCV, PLT-CT, RBC, MCH, NTAUTO, NEUTRE, LYMPRE, NEUTAB, LYMPAB, CL, AND GLUC. IT WAS FURTHER NOTED THE PATIENT¿S LAB RESULTS FOR (B)(6) 2013 WERE ELEVATED GLUBED, HGB, PCV, PLT-CT, RBC, MCH, NEUTRE, LYMPRE, LUYMPAB, CL, AND GLUC. IT WAS NOTED THE PATIENT¿S LAB RESULTS FOR (B)(6) 2013 WERE ELEVATED HGB, PCV, PLT-CT, RBC<(><<)> MHC, NEUTRE, LYMPRE, LYMPAB, AND GLUC. IT WAS NOTED THE ETIOLOGY WAS NEW ILLNESS OR CONDITION NOT RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. IT WAS FURTHER NOTED THE PATIENT SYMPTOMS WERE HIGH BLOOD PRESSURE 200/130 AND RESULTED IN HOSPITALIZATION. IT WAS NOTED THE PATIENT OUTCOME WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THE LAB WORK RESULTS WERE UPDATED TO ELEVATED HGB, RBC, MCH, LYYMPAB, AND GLUC. ON (B)(6) 2013, ELEVATED HGB, RBC, MCH, LYMPAB, AND GLUC ON (B)(6) 2013, AND ELEVATED MCH, NEUTRE, LYMPRE, LYMPAB, AND GLUC. ON (B)(6) 2013. IT WAS NOTED THE PATIENT OUTCOME WAS UPDATED TO RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469486 LEAD, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R