BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4812779 · Received June 2, 2015

    Report

    Report Number
    3007566237-2015-01519
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ATTACHED REPORT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GONE IN FOR A WEEKLY VISIT AND HAD DESCRIBED HER DEPRESSION WAS WORSENING. THE PATIENT WAS TEARFUL, REPORTED NEGATIVE THOUGHTS AND SLIGHT DECREASE IN ENERGY. OVER ALL THE PATIENT¿S MOOD WAS LOW BUT WAS STILL INFLUENCED BY EXTERNAL EVENTS. THE PATIENT HAD NO DIFFICULTY SLEEPING, INTEREST IN THE HOLIDAYS AND SHE HAD STARTED A NEW DIET. THE PATIENT HAD CALLED IN AGAIN DUE TO WORSENING DEPRESSION; HER MOOD WAS DESCRIBED AS VERY LOW AND SHE HAD BEEN ADVISED TO GO IN FOR AN UNSCHEDULED FOLLOW UP VISIT WITH HER HEALTHCARE PROFESSIONAL WHERE SHE WAS AGAIN TEARFUL BUT WAS ABLE TO BRIGHTEN UP AT TIMES DURING THE CONVERSATION. THE HEALTHCARE PROFESSIONAL BEGAN DOWN TITRATING HER MEDICATION, TRILEPTAL. PATIENT WAS INSTRUCTED TO SEEK IMMEDIATE MEDICAL ATTENTION IF HER DEPRESSION WORSENED. AT THAT TIME THE PATIENT HAD DENIED ANY SUICIDAL IDEATIONS BUT DID SOMETIMES THINK SHE WOULD BE BETTER OFF NOT BEING HERE. THE PATIENT HAD STARTED DOWN TITRATING TRILEPTAL AND DENIED ANY SUICIDAL IDEATIONS AND HER MOOD WAS THE SAME AS THE DAY PRIOR. THE PATIENT HAD EXPRESSED WORSENING OF SYMPTOMS AND THAT SHE WAS SUICIDAL. THE PATIENT HAD SPOKEN TO THE HEALTHCARE PROFESSIONAL LATER AND HAD NOTED THAT SHE WAS OKAY AND NOT SUICIDAL ANYMORE. AGAIN PATIENT EXPRESSED WORSENING OF DEPRESSION; PATIENT HAD DECREASE IN OVERALL MOOD, TEARFULNESS, LASSITUDE AND A DECREASE IN ENERGY. THE PATIENT WAS ALSO RUMINATING ON HER HUSBAND BEING UPSET AT HER. ARRANGEMENTS WERE MADE FOR THE PATIENT TO BE HOSPITALIZED ON THE MOOD DISORDER SPECIALTY UNIT WHERE THE PATIENT WAS VOLUNTARILY ADMITTED. THE PATIENT WAS GOING TO CONTINUE WEEKLY FOLLOW UP AND WOULD BE MONITORED DAILY FOR PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE REPORTED DIAGNOSTICS INCLUDED THE PATIENT WAS HOSPITALIZED AND CURRENT MOOD SCALES WERE PERFORMED (MADRS, YMRS, AND CGI-S). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THEY HAD CONTINUED THEIR STUDY PARTICIPATION. AT THE TIME OF REPORT, THE PATIENT WAS 43 WEEKS POST-SURGERY AND OVERALL HER DEPRESSION WAS IN PARTIAL REMISSION. THE PATIENT DESCRIBED SOME FAMILIAL STRESSORS WHICH SHE BELIEVED TO HAVE LED TO HER WORSENING OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356601 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O