BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN NEUROSTIMULATOR

    MDR report key: 6198907 · Received December 22, 2016

    Report

    Report Number
    3007566237-2016-04516
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 13, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A HEALTHCARE PROFESSIONAL (HCP) FOR A CLINICAL STUDY REPORTED VIA A REPRESENTATIVE THAT THERE WAS A DIAGNOSIS OF DEVICE INFECTION WHICH REQUIRED HOSPITALIZATION. THE PATIENT PRESENTED AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 FOR INCREASED SWELLING AND PAIN SURROUNDING IMPLANTED RIGHT CHEST BATTERY DEVICE FOLLOWING SURGERY INSERTION ON (B)(6) 2016. BLOOD TESTS SHOWED RAISED CRF (CORTICOTROPHIN-RELEASING HORMONE) OF 105 AND NORMAL WHITE CELL COUNT; INTRAVENOUS (IV) FLUCLOXACILLIN WAS COMMENCED ON (B)(6) 2016. THE PATIENT WAS TRANSFERRED AND ADMITTED TO ANOTHER HOSPITAL ON (B)(6) 2016 AND WAS ASSESSED BY HCPS FOR FURTHER TREATMENT AND INFECTION CONTROL ADVICE, INCLUDING BLOOD TESTS AND IV ANTIBIOTICS. DEVICE SITE INFECTION WAS DIAGNOSED ON (B)(6) 2016 WITH SOME MILD ERYTHEMA AND SWELLING AROUND THE BATTERY SITE. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED. FOLLOW-UP APPOINTMENTS WITH THE HCPS OCCURRED ON (B)(6) 2016. THE IV ANTIBIOTICS, WHICH WERE ADMINISTERED FROM (B)(6) 2016 UNTIL DISCHARGE, SETTLED THE ERYTHEMA AND SWELLING. THE PATIENT REMAINED ON ORAL ANTIBIOTICS SINCE DISCHARGE AND HAD A FOLLOW-UP APPOINTMENT SCHEDULED FOR (B)(6) 2016. THE OUTCOME WAS DESCRIBED AS ¿CONTINUING¿ BUT THE EVENT DID NOT REQUIRE DEVICE REMOVAL. RELATIONSHIP TO DEVICE WAS ¿PROBABLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850143 UNKNOWN DEEP BRAIN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R