BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1111559 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04920
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 29, 2005
    Report Date
    July 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    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

    (FOR HALLUCINATIONS, VIOLENT BEHAVIOR, ILLICIT DRUG USE, WANDERING AND IRRITABILITY).

    Description of Event or Problem · 1

    THE PT WAS DISCHARGED FROM AN OVERNIGHT STAY IN THE HOSP DUE TO IMPROVEMENT OF AN AGITATION STATE IN 2005. THE PT HAD RECURRENT AGITATION AND UNCONTROLLABLE BEHAVIOR APPROX 2 DAYS AFTER DISCHARGE. HE HAD MILD HALLUCINATIONS, STRUCK FAMILY MEMBERS, AND CALLED 911. THE PT WAS TAKEN TO A LOCAL COMMUNITY HOSP ER AND RELEASED. THE TREATMENT HE REC'D THERE WAS UNK. THE PT WAS BROUGHT TO ANOTHER HOSP AND ADMITTED TO PSYCHIATRY FOR FURTHER EVAL. A WORKUP OF BLOOD TESTS, DRUG SCREEN, ELECTROCARDIOGRAM, AND CHEST X-RAY WERE NORMAL. PULSE OXIMETRY ON ROOM AIR WAS GREATER THAN 95%. THE PT WAS EVICTED FROM THE LIVING FACILITY DUE TO ONGOING BEHAVIORAL ISSUES IN 2006. THE OWNER DESCRIBED WANDERING IN THE EVENING AND AN INABILITY TO PROVIDE THE LEVEL OF CARE NECESSARY FOR THE PT. THE PT IS KNOWN TO STUDY PERSONNEL AS ONE WHO ROUTINELY TAKES 1-2 MILE WALKS IN THE EVENING NOT INTERPRETED AS WANDERING, AND AT TIMES HAS REPORTED FALLS. THE PT WAS HOSPITALIZED UNTIL AN ALTERNATIVE LIVING FACILITY WAS FOUND. THE PT WAS PLACED IN A SKILLED NURSING FACILITY. THE HCP REPORTS THE EVENTS MAY BE RELATED TO BASELINE AGGRESSIVENESS, PD/DEMENTIA PROGRESSION AND/OR POSSIBLE ILLICIT DRUG USE. THE FOLLOWING MONTH, THE PT HAD A POSITIVE URINE SCREEN FOR AMPHETAMINES. IN 2007, IT WAS REPORTED THAT THE PT HAD BEEN ADMITTED THROUGH THE ER FOR AGGRESSIVE BEHAVIOR, WANDERING, AGITATION AND IRRITABILITY, WAS "THROWING HIMSELF ON FLOOR", AND ALLEGING THAT HE HAD A BROKEN ARM. HE WAS HOSPITALIZED FOR COGNITIVE DISORDER WITH BEHAVIOR DISTURBANCES AND WAS ADMITTED TO THE PSYCHIATRY AND PSYCHOTHERAPY UNITS TO RECEIVE GROUP AND MILIEU THERAPY. NO NEW PROBLEMS AROSE DURING THE COURSE OF HIS HOSPITALIZATION; HE RECOVERED FROM THE STRESS OF HIS SOCIAL AND LIVING ENVIRONMENT AND WAS DISCHARGED WITH A DIAGNOSIS OF COGNITIVE DISORDER WITH BEHAVIOR DISTURBANCES. THE PT HAD A HISTORY OF MULTIPLE BEHAVIOR PROBLEMS ATTRIBUTED TO PERSONALITY DISORDER, COGNITIVE PROBLEMS AND ANXIETY DISORDER. THE HCP REPORTED THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE STIMULATOR THERAPY, OR PROBABLY RELATED TO PROGRESSION OF PT. A CT BRAIN SCAN TAKEN IN 2007, REVEALED NO ACUTE ABNORMALITY. THE ADMISSIONS AS WELL AS OTHER RELATED ANXIETY DISORDER AND DEMENTIA HAVE BEEN ONGOING DURING THE COURSE OF STUDY. THE PRINCIPLE INVESTIGATOR DEEMED THE REASON FOR ADMISSION AND THE FINAL SERIOUS ADVERSE EVENT BE CLARIFIED AND ENCOMPASSED UNDER ONE EVENT, 'BEHAVIOR PROBLEMS'. REFER TO MFR REPORT # 6000153-2007-02920, 6000153-20070-02919, 2649622-2005-01273, 2649622-2005-01274.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R LEAD MODEL 3387| EXTENSION MODEL 7482| MEDICATIONS: SINEMET| EXPLANTED| LEAD MODEL 3387| EXTENSION MODEL 74282| EXPLANTED| CELEXA| OMEPRAZOLE| ROPINIROLE| ENTACAPONE| ARICEPT| REQUIP| SENNOSIDES| AMANTADINE| DEPAKOTE| EXPLANTED| TRAZADONE| SIMVASTATIN| EXPLANTED| SINEMET CR| METOPROLOL| UBILIFY