BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3477160 · Received November 19, 2013

    Report

    Report Number
    3004209178-2013-21053
    Event Type
    Injury
    Date Received
    November 19, 2013
    Report Date
    October 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3550-09 LOT# N218893, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3391S-40 LOT# V159369, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3550-09 LOT# N218893, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3391S-40 LOT# V159369, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3550-09, LOT# N218893, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3391S-40, LOT# V159369, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-09, LOT# N218893, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3391S-40, LOT# V159369, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SISTER HAD RECEIVED A 7-PAGE LETTER FROM THE PATIENT ONE WEEK PRIOR TO THE REPORT, WHICH WAS DESCRIBED AS "NOT RATIONAL... DOESN'T MAKE SENSE," AND DISORGANIZED - IN THE LETTER, HE WROTE THAT HE WAS "SPIRALING INTO PAIN," AND WANTED TO "GO AWAY AND LIVE COMPLETELY IN NATURE AND OUT OF CONTACT WITH THE REST OF HUMANITY FOR THE REST OF MY LIFE." IT WAS STATED, HE EXPRESSED SUICIDAL INTENT, WITH UNCLEAR IMMINENCE. THE PATIENT "WAS ON DISABILITY" AND HAD WRITTEN THAT HE HAD STOPPED USING HIS DEEP BRAIN STIMULATION (DBS) IMPLANT, AND "GONE OFF ALL HIS MEDS." HIS MEDICATIONS INCLUDED: ABILIFY (ARIPIPRAZOLE) 5 MG (10 MG TABLET TAKE 0.5) PO QD X 28 DAYS; NO CHANGE, COMMENTS: SAMPLE PROVIDED TO PT TODAY KLONOPIN (CLONAZEPAM) 1 MG (1 MG TABLET TAKE 1) PO QHS PRN INSOMNIA, DEA AT 9729433-3430 X 30 DAYS; NO CHANGE , COMMENTS: 1 MG LAMOTRIGINE 200 MG (200 MG TABLET TAKE 1) PO QD X 60 DAYS; NO CHANGE NIFEDIPINE (IMMEDIATE RELEASE) 10 MG (10 MG CAPSULE TAKE 1) PO AS DIRECTED PRN SIGNS AND SYMPTOMS OF HYPERTENSIVE CRISIS, TAKE 1 TABLET (10 MG) PRN SIGNS AND SYMPTOMS OF HYPERTENSIVE CRISIS X 5 DAYS; NO CHANGE PARNATE (TRANYLCYPROMINE) 10 MG TABLET AS DIRECTED , TAKE 3 TABLETS BY MOUTH TWICE A DAY. (SIG. 30MG PO BID) X 30 DAYS; NO CHANGE PRAMIPEXOLE 0.25 MG (0.25 MG TABLET TAKE 1) PO TID; NO CHANGE TAMSULOSIN 0.8 MG (0.4 MG CAP ER 24H TAKE 2) PO QD; NO CHANGE IT WAS ALSO REPORTED THAT THE POLICE HAD BEEN UNSUCCESSFULLY SEARCHING FOR THE PATIENT. IT WAS ALSO NOTED THAT, EVEN THOUGH SHE HAS BEEN TREATING HIM FOR THE PAST YEAR, PATIENT'S PSYCHIATRIST HAD NOT FORESEEN HIS DISAPPEARANCE <(>&<)> ALSO DID NOT KNOW WHERE HE MIGHT HAVE GONE. IT WAS REPORTED THAT THE PATIENT HAD RUN AWAY - SUPPOSEDLY INTO THE WILD- AND COULDN'T BE TRACKED DOWN, AT LEAST NOT YET. IT WAS STATED THAT, BASED ON THIS INFORMATION, IT SEEMED UNLIKELY THAT THE (B)(6) 2013 SURGERY WOULD STILL BE HAPPENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT HAD RUN AWAY "INTO THE WILD" IN (B)(6) PRIOR TO THE DATE OF THIS REPORT AND HAD NOT BEEN LOCATED OR HEARD FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598264 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Other