BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1993191 · Received January 13, 2011

    Report

    Report Number
    3004209178-2011-00338
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR DEEP BRAIN STIMULATION (DBS) IMPLANTATION FOR OBSESSIVE COMPULSIVE DISORDER (OCD). THE PATIENT HAD A HISTORY OF OCD AND DEPRESSION WITH PRIOR SUICIDE ATTEMPTS. HER SURGICAL RECOVERY WAS UNEVENTFUL. ON (B)(6) 2010, THE PATIENT'S INITIAL DBS PROGRAMMING WAS COMPLETED. SHE EXHIBITED IMPROVEMENT IN MOTIVATION, ACTIVITY AND MOOD. APPROXIMATELY SIX WEEKS AFTER DBS IMPLANTATION, ON (B)(6) 2010, THE PATIENT WAS FOUND UNRESPONSIVE IN HER HOTEL ROOM, TRANSPORTED TO THE EMERGENCY DEPARTMENT AT (B)(6), INTUBATED AND INITIALLY ASSESSED AS HAVING MADE A SUICIDE ATTEMPT. HOWEVER, SEVERAL HOURS AFTER ADMISSION TO THE ICU, SHE WAS DIAGNOSED WITH PULMONARY EMBOLISM. THE PATIENT'S TOXICOLOGY SCREEN WAS POSITIVE FOR BENZODIAZEPINES, HOWEVER, THIS WAS EXPECTED AS SHE WAS ON PRESCRIBED BENZODIAZEPINES. THE MEDICINE TEAM FELT HER LABS AND CLINICAL PICTURE WERE NOT CONSISTENT WITH AN OVERDOSE. SHE HAD A HISTORY OF CHRONIC, SEVERE INSOMNIA AND WAS PRESCRIBED CLONAZEPAM FOR TREATMENT OF INSOMNIA. AN INVENTORY OF HER MEDICATIONS REVEALED THAT SHE MAY HAVE TAKEN CLONAZEPAM TABLETS IN EXCESS OF THE EXPECTED AMOUNT. SHE WAS INTUBATED FOR FOUR DAYS. ON (B)(6) 2010, SHE WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, THE PATIENT REPORTED TO THE (B)(6) DURING AN OUTPATIENT VISIT THAT SHE HAD HAD SEVERE INSOMNIA FOR THREE DAYS PRIOR TO HER HOSPITALIZATION AND TOOK MORE THAN THE PRESCRIBED AMOUNT OF CLONAZEPAM TO TREAT HER INSOMNIA. SHE DENIED ANY ATTEMPT TO HARM HERSELF OR COMMIT SUICIDE. ON (B)(6) 2011, THE (B)(6) CONFERRED WITH THE TREATING PSYCHIATRIST AND, EVEN THOUGH, THE PATIENT DENIES THAT THIS WAS A SUICIDE ATTEMPT, IT WAS FELT THAT THE POSSIBILITY OF A SUICIDE ATTEMPT COULD NOT BE RULED OUT. THE PRESUMPTION IS THAT THE PATIENT TOOK ENOUGH CLONAZEPAM TO BE IMMOBILE IN BED FOR AN EXTENDED PERIOD OF TIME, WHICH THEN RESULTED IN A PULMONARY EMBOLISM. A HYPER-COAGULABLE WORKUP IS IN PROGRESS BY THE INTERNAL MEDICINE SERVICE. THE TREATING PSYCHIATRIST HAS DETERMINED THAT A SUICIDE ATTEMPT CANNOT BE RULED OUT, POSSIBLY RELATED TO DBS SURGERY. THE (B)(6) HAS ASSESSED THE EVENT AS UNLIKELY TO BE A SUICIDE ATTEMPT PER PATIENT REPORT, AND HAS ASSESSED THE PATIENT'S UNRESPONSIVENESS AND HOSPITALIZATION AS LIKELY DUE TO AN INADVERTENT CLONAZEPAM OVERDOSE AND SUBSEQUENT PULMONARY EMBOLISM, UNLIKELY RELATED TO DBS SURGERY. THE PATIENT IS DOING MUCH BETTER NOW, AS WELL AS SHE HAS IN MANY YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening IMPLANTED:| LEAD: MODEL 3391S-40, LOT# V257753| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU208639V| EXPLANTED:| LEAD: MODEL 3391S-40, LOT# V259776| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU209385V| IMPLANTED:| EXPLANTED:| IMPLANTED: