BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6712344 · Received July 13, 2017

    Report

    Report Number
    3007566237-2017-02864
    Event Type
    Death
    Date Received
    July 13, 2017
    Date of Event
    January 1, 2009
    Report Date
    July 13, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED AGE REFLECTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. THE REPORTED SEX REFLECTS THAT OF THE MAJORITY OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ABRECHT CR, GREENBERG P, SONG E, URMAN RD, RATHMELL JP. A CONTEMPORARY MEDICOLEGAL ANALYSIS OF IMPLANTED DEVICES FOR CHRONIC PAIN MANAGEMENT. ANESTH ANALG. 2017;124(4):1304-1310. DOI: (B)(6). SUMMARY: ANALYSIS OF CLOSED MALPRACTICE CLAIMS ALLOWS THE STUDY OF RARE BUT SERIOUS COMPLICATIONS AND LIKELY RESULTS IN IMPROVED PATIENT SAFETY BY RAISING AWARENESS OF SUCH COMPLICATIONS. CLINICAL STUDIES AND CLOSED CLAIMS ANALYSES HAVE PREVIOUSLY REPORTED ON THE COMMON COMPLICATIONS ASSOCIATED WITH INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) AND SPINAL CORD STIMULATORS (SCS). THIS STUDY PROVIDES A CONTEMPORARY ANALYSIS OF CLAIMS FROM WITHIN THE PAST 10 YEARS. WE PERFORMED A CLOSED CLAIMS ANALYSIS FOR A PERIOD JANUARY 1, 2009 TO DECEMBER 31, 2013 FOR CASES WITH PAIN MEDICINE AS THE PRIMARY SERVICE. THESE CASES WERE IDENTIFIED USING THE CONTROLLED RISK INSURANCE COMPANY (CRICO) COMPARATIVE BENCHMARKING SYSTEM (CBS), A DATABASE CONTAINING MORE THAN 300,000 MALPRACTICE CLAIMS FROM MORE THAN 400 ACADEMIC AND COMMUNITY INSTITUTIONS, REPRESENTING APPROXIMATELY 30% OF MALPRACTICE CASES IN THE UNITED STATES. THE CLINICAL NARRATIVES, WHICH INCLUDED MEDICAL FILES, CLAIMS FILES, DEPOSITIONS, AND EXPERT WITNESS TESTIMONY, WERE REVIEWED BY THE AUTHORS, AS WERE THE CRICO CODED VARIABLES, WHICH INCLUDED ALGORITHMICALLY DETERMINED CONTRIBUTING FACTORS TO THE PATIENT INJURY. REPORTED EVENTS: THE CHRONIC PAIN DIAGNOSIS FOR IDDS (INTRATHECAL DRUG DELIVERY SYSTEM) IMPLANTATION INCLUDED 5 CASES OF FAILED BACK SURGERY SYNDROME, 5 CASES OF DEGENERATIVE JOINT DISEASE WITH LUMBAR RADICULOPATHY, 3 CASES OF SPASTICITY, ONE CASE OF COMPLEX REGIONAL PAIN SYNDROME, ONE CASE OF MALIGNANCY, ONE CASE OF CEREBROVASCULAR INFARCT-TRIGGERED CENTRAL PAIN, AND ONE CASE WAS NOT AVAILABLE. THERE WERE FIVE CASES OF IDDS (INTRATHECAL DRUG DELIVERY SYSTEM) REFILL ERRORS. THESE ALLEGED DAMAGING EVENTS INCLUDED A RELATIVELY BENIGN CASE WHEREIN AN INTENTIONAL IDDS DOSE INCREASE WAS JUDGED TO BE WITHIN THE STANDARD OF CARE RESULTED IN PATIENT SEDATION. OTHER CASES INCLUDED ACCIDENTAL SUBCUTANEOUS INJECTION OF 100 MCG/ML SUFENTANIL BY A REGISTERED NURSE IN AN OBESE PATIENT WITH ABDOMINAL SCAR TISSUE, AN ACCIDENTAL 6-FOLD INTRATHECAL MEDICATION DOSE INCREASE PERFORMED BY A MEDICAL ASSISTANT, AND AN ACCIDENTAL 20-FOLD DOSE INCREASE PERFORMED BY A PHYSICIAN. THE MEDIUM SEVERITY OUTCOMES INCLUDED DRUG REACTIONS, ALL FROM PUMP REFILL ERRORS AND RANGED FROM SOMNOLENCE TO RESPIRATORY ARREST REQUIRING INTENSIVE CARE UNIT ADMISSION AND NALOXONE INFUSION. THERE WERE THREE CASES OF INTRATHECAL GRANULOMA. INTRATHECAL GRANULOMA FORMATION WAS MARKED IN ALL CASES BY A DECREASED ANALGESIC EFFECT DESPITE AN INCREASED DOSE OF INTRATHECAL MEDICATIONS. DIAGNOSTIC INTERVENTIONS WERE DELAYED UNTIL AFTER NEUROLOGIC DEFICITS HAD DEVELOPED. INVOLVED AGENTS INCLUDED INTRATHECALLY DELIVERED MORPHINE AND, IN 1 CASE, METHADONE. THERE WERE TWO CASES OF PULMONARY EMBOLISM. THE CASES HAD A HIGH-SEVERITY OUTCOME OF DEATH, WHICH WERE ATTRIBUTED TO PULMONARY EMBOL I. THERE WERE TWO CASES OF POST-OPERATIVE INFECTION. THE EVENTS INCLUDED SOFT TISSUE AND EPIDURAL ABSCESS FORMATION RELATED MOST OFTEN TO THE INFECTION SURROUNDING A DEVICE COMPONENT. IN ONE CASE, A PATIENT WHO WENT SWIMMING AGAINST MEDICAL ADVICE AFTER IDDS IMPLANTATION DEVELOPED PSEUDOMONAS MENINGITIS. THERE WAS ONE CASE OF INTRA-OPERATIVE NERVE DAMAGE. THERE WAS ONE CASE OF EPIDURAL HEMATOMA. THERE WAS ONE CASE OF A DEFECTIVE DEVICE (RECALLED). THERE WAS ONE CASE OF POST-OPERATIVE MECHANICAL DAMAGE TO THE DEVICE. THERE WERE THREE CASES WITH A HIGH-SEVERITY OUTCOME OF NERVE DAMAGE. THESE NERVE DAMAGE OUTCOMES RANGED FROM IT (INTRATHECAL) GRANULOMA-RELATED PARAPLEGIA AND EPIDURAL ABSCESS-RELATED QUADRIPLEGIA REQUIRING TRACHEOSTOMY, ENTERIC FEEDING TUBE, AND PLACEMENT IN LONG-TERM CARE FACILITY. THERE WERE THREE CASES WITH A MEDIUM-SEVERITY OUTCOME WHICH NEEDED RE-OPERATION, MOST COMMONLY BECAUSE OF THE RETAINED DEVICE COMPONENT OR INFECTION. THERE WERE TWO CASES WITH A MEDIUM-SEVERITY OUTCOME OF NERVE DAMAGE. THERE WAS ONE CASE WITH A MEDIUM-SEVERITY OUTCOME OF SAME/WORSE SYMPTOMS. COMPLAINTS OF NO IMPROVEMENT OR WORSENING OF SYMPTOMS (EG, PAIN, URINARY INCONTINENCE) WERE A COMMON OUTCOME. THE CONTRIBUTING FACTORS, AS CODED BY CRICO (CONTROLLED RISK INSURANCE COMPANY), WERE NOTED AS 8 CASES OF TECHNICAL SKILL, 5 CASES OF CLINICAL JUDGEMENT, 2 CASES OF COMMUNICATION, 2 CASES OF DOCUMENTATION, 2 CASES OF PATIENT BEHAVIOR, 2 CASES OF SUPERVISION OF STAFF OR SUPERVISION OF TRAINEE, 3 CASES OF EQUIPMENT-RELATED, AND ONE CASE OF NO RISK MANAGEMENT ISSUES IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491147 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H| L| R