BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 2557112 · Received May 2, 2012

    Report

    Report Number
    3007566237-2012-00957
    Event Type
    Death
    Date Received
    May 2, 2012
    Date of Event
    December 1, 2011
    Report Date
    April 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IMPLANTED: UNK EXPLANTED: UNK; PRODUCT TYP CATHETER. THE ACTUAL DATES WERE NOT PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENT REPORTED WITH PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    BRONSTEIN, A. C., SPYKER, D. A., CANTILENA, L. R., GREEN, J. L., RUMACK, B. H., DART, R. C. 2010 ANNUAL REPORT OF THE AMERICAN ASSOCIATION OF POISON CONTROL CENTERS' NATIONAL POISON DATA SYSTEM (NPDS): 28TH ANNUAL REPORT. CLINICAL TOXICOLOGY 2011. 49: 910-941. DOI: 10.3109/15563650.2011.635149. SUMMARY: THIS IS THE 28TH ANNUAL REPORT OF THE AMERICAN ASSOCIATION OF POISON CONTROL CENTERS' (AAPCC) NATIONAL POISON DATA SYSTEM (NPDS). ALL US POISON CENTERS UPLOAD CASE DATA AUTOMATICALLY WITH A MEDIAN TIME INTERVAL OF 19.0 [11.9, 40.6] (MEDIAN [25%, 75%]) MINUTES, CREATING A NEAR REAL-TIME NATIONAL EXPOSURE AND INFORMATION DATABASE AND SURVEILLANCE SYSTEM. WE ANALYZED THE CASE DATA TABULATING SPECIFIC INDICES FROM NPDS. THE METHODOLOGY WAS SIMILAR TO THAT OF PREVIOUS YEARS. WHERE CHANGES WERE INTRODUCED, THE DIFFERENCES ARE IDENTIFIED. POISON CENTER CASES WITH MEDICAL OUTCOMES OF DEATH WERE EVALUATED BY A TEAM OF 33 MEDICAL AND CLINICAL TOXICOLOGIST REVIEWERS USING AN ORDINAL SCALE OF 1 (UNDOUBTEDLY RESPONSIBLE) - 6 (UNKNOWN) TO DETERMINE RELATIVE CONTRIBUTION TO FATALITY (RCF) OF THE EXPOSURE TO THE DEATH. IN 2010, 3 ,952,772 CLOSED ENCOUNTERS WERE LOGGED BY NPDS: 2,384,825, HUMAN EXPOSURES, 94,823 ANIMAL EXPOSURES, 1,466,253 INFORMATION CALLS, 6537 HUMAN CONFIRMED NONEXPOSURES, AND 334 ANIMAL CONFIRMED NONEXPOSURES. TOTAL ENCOUNTERS SHOWED A 7.7% DECLINE FROM 2009 WHILE HEALTH CARE FACILITY CALLS INCREASED BY 2.7%. HUMAN EXPOSURES WITH MORE SERIOUS OUTCOMES (MINOR, MODERATE, MAJOR OR DEATH) INCREASED 4.5% WHILE THOSE WITH LESS SERIOUS OUTCOMES (ALL OTHER MEDICAL OUTCOME CATEGORIES) DECREASED 5.9%. ALL INFORMATION CALLS DECREASED 12.6% AND HEALTH CARE FACILITY (HCF) INFORMATION CALLS DECREASED 13.6%, DRUG ID CALLS DECREASED 10.9%, AND HUMAN EXPOSURES DECREASED 3.8%. THE TOP 5 SUBSTANCE CLASSES MOST FREQUENTLY INVOLVED IN ALL HUMAN EXPOSURES WERE ANALGESICS (11.5%), COSMETICS/PERSONAL CARE PRODUCTS (7.7%), HOUSEHOLD CLEANING SUBSTANCES (7.3%), SEDATIVES/HYPNOTICS/ ANTIPSYCHOTICS (6.0%), AND FOREIGN BODIES/TOYS/MISCELLANEOUS (4.2%). ANALGESIC EXPOSURES AS A CLASS INCREASED THE MOST RAPIDLY BY 32.8% OVER THE LAST DECADE. THE TOP FIVE MOST COMMON EXPOSURES IN CHILDREN AGE 5 YEARS OR LESS WERE COSMETICS/PERSONAL CARE PRODUCTS (13.2%), ANALGESICS (9.4%), HOUSEHOLD CLEANING SUBSTANCES (9.2%), FOREIGN BODIES/TOYS/MISCELLANEOUS (7.2%), AND TOPICAL PREPARATIONS (6.8%). THC HOMOLOG AND DESIGNER AMPHETAMINE ("BATH SALTS") EXPOSURES WERE IDENTIFIED AS EMERGING PUBLIC HEALTH THREATS. DRUG IDENTIFICATION REQUESTS COMPRISED 64.3% OF ALL INFORMATION CALLS. NPDS DOCUMENTED 1730 HUMAN EXPOSURES RESULTING IN DEATH WITH 1146 HUMAN FATALITIES JUDGED RELATED WITH AN RCF OF 1-UNDOUBTEDLY RESPONSIBLE, 2-PROBABLY RESPONSIBLE, OR 3-CONTRIBUTORY. THESE DATA SUPPORT THE CONTINUED VALUE OF POISON CENTER EXPERTISE AND NEED FOR SPECIALIZED MEDICAL TOXICOLOGY INFORMATION TO MANAGE THE MORE SEVERE EXPOSURES, DESPITE A DECREASE IN CALLS INVOLVING LESS SEVERE EXPOSURES. UNINTENTIONAL AND INTENTIONAL EXPOSURES CONTINUE TO BE A SIGNIFICANT CAUSE OF MORBIDITY AND MORTALITY IN THE US. THE NEAR REAL-TIME, ALWAYS CURRENT STATUS OF NPDS REPRESENTS A NATIONAL PUBLIC HEALTH RESOURCE TO COLLECT AND MONITOR US EXPOSURE CASES AND INFORMATION CALLS. THE CONTINUING MISSION OF NPDS IS TO PROVIDE A NATIONWIDE INFRASTRUCTURE FOR PUBLIC HEALTH SURVEILLANCE FOR ALL TYPES OF EXPOSURES, PUBLIC HEALTH EVENT IDENTIFICATION, RESILIENCE RESPONSE AND SITUATIONAL AWARENESS TRACKING. NPDS IS A MODEL SYSTEM FOR THE NATION AND GLOBAL PUBLIC HEALTH. CASE 1135: THIS (B)(6) MALE HAD AN INTRATHECAL CATHETER FOR BACLOFEN INFUSION. HE UNDERWENT ELECTIVE SPINAL FUSION FOR SCOLIOSIS AND REVISION OF HIS INTRATHECAL CATHETER FOR BACLOFEN INFUSION WHICH HAD BEEN INITIATED MANY YEARS AGO. ONE DAY AFTER SURGERY, HE DEVELOPED INCREASED MUSCLE TONE AND AGITATION WHICH WERE ATTRIBUTED TO BACLOFEN OR BENZODIAZEPINE WITHDRAWAL, SO HE WAS RETURNED TO SURGERY FOR REVISION OF THE INTRATHECAL ACCESS PLACEMENT. HE DID WELL AND WAS TRANSFERRED OUT OF ICU DAY 2 AFTER INITIAL SURGERY, BUT 1 DAY LATER, HE DEVELOPED FEVER TO 41.7 DEGREES C WITH AGITATION, HALLUCINATIONS, MUSCLE RIGIDITY AND CLONUS. HIS BACLOFEN INFUSION RATE WAS ADJUSTED, COOLING AND ACETAMINOPHEN WERE PROVIDED. ON DAY 3, HE WAS GIVEN HALOPERIDOL FOR AGITATION AND HALLUCINATIONS WITHOUT SIGNIFICANT IMPROVEMENT. TREATMENT WITH DANTROLENE WAS BEGUN ON DAY 4 AND HE IMPROVED SOMEWHAT WITH T 39.4 DEGREES C AND HEART RATE 120S, AND WAS WELL-SEDATED ON LORAZEPAM WITH NO BREAKTHROUGH AGITATION. HOWEVER, ON DAY 5, HE DEVELOPED RESPIRATORY DEPRESSION AND HYPOTENSION AND RHABDOMYOLYSIS WITH A CREATINE KINASE OF 300,000, INCREASED ASPARTATE TRANSAMINASE, GI BLEEDING AND THROMBOCYTOPENIA. THE FINDINGS WERE THOUGHT TO REPRESENT BACLOFEN WITHDRAWAL SO THE BACLOFEN INFUSION RATE WAS INCREASED AND THE CONCENTRATIONS IN THE RESERVOIR AND CSF (120 MCG/ML) WERE CONFIRMED. DAILY HEMODIALYSIS WAS BEGUN. HE CONTINUED TO REQUIRE VASOPRESSOR SUPPORT AND EXTERNAL COOLING, ANTIBIOTIC THERAPY WAS INITIATED EMPIRICALLY. LEVETIRACETAM AND PHENYTOIN WERE ADDED FOR SEIZURE ACTIVITY WHICH CONTINUED DESPITE THE ADDITION OF PROPOFOL, MIDAZOLAM AND FENTANYL AND HE BECAME ANURIC. MIDAZOLAM AND PROPOFOL WERE DISCONTINUED AFTER SEIZURE ACTIVITY RESOLVED. HE MAINTAINED PUPILLARY AND GAG REFLEXES BUT WAS RESPONSIVE ONLY TO PAINFUL STIMULI. GOALS OF CARE WERE CHANGED TO COMFORT ONLY, AND HE DIED ON DAY 27. AN AUTOPSY WAS NOT PERFORMED. IT WAS NOT SPECIFIED WHETHER THE DRUG INVOLVED WAS COMPOUNDED BACLOFEN OR LIORESAL. PER FOLLOW-UP WITH THE AAPCC, THE DATA ARE DE-IDENTIFIED AND REPRESENT DATA ABOUT CALLS PLACED TO ONE OF THE NATION'S 57 POISON CENTERS. FOR THIS PARTICULAR CASE, THE FATALITY ABSTRACT IS PUBLISHED IN THE APPENDIX OF THE ANNUAL REPORT AND THIS REPRESENTS ALL THE DATA THAT IS AVAILABLE FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Death| H| R PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN