BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2478182 · Received March 5, 2012

    Report

    Report Number
    3007566237-2012-00460
    Event Type
    Death
    Date Received
    March 5, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS AN APPROXIMATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN THE ARTICLE IT WAS ALSO REPORTED THAT THERE HAD BEEN 41 PUMP REPLACEMENTS DURING THE STUDY, "AN AVERAGE OF 2.05 ± 0.18 PUMP REPLA CEMENTS (RANGE: 1 TO 3) WERE PERFORMED AT A MEAN FOLLOW-UP PERIOD OF 4.95 ± 0.39 YEARS (RANGE 3 TO 9) FOR THE FIRST REPLACEMENT 9.86 ± 0.67 YEARS (RANGE 7 TO 16) FOR THE SECOND REPLACEMENT, AND 14.43 ± 0.89 YEARS (RANGE: 11 TO 17) FOR THE THIRD REPLACEMENT."

    Description of Event or Problem · 1

    LITERATURE: DUARTE RV, RAPHAEL JH, SPARKES E, SOUTHALL JL, LEMARCHAND K, ASHFORD RL. LONG-TERM INTRATHECAL DRUG ADMINISTRATION FOR CHRONIC NONMALIGNANT PAIN. JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY. 2012;24(1):63-70. (B)(4): THE AUTHORS REPORTED THAT TWENTY PATIENTS PARTICIPATED IN A LONGITUDINAL STUDY WITH AN AVERAGE FOLLOW-UP OF 13.5 YEARS (RANGE: 10.4 TO 17.9) AFTER INTRATHECAL DRUG DELIVERY SYSTEM (IDDS) IMPLANTATION. INVESTIGATION WAS CARRIED OUT BY MEANS OF A QUESTIONNAIRE BEFORE IDDS AND AFTER AN AVERAGE OF 4 AND 13 YEARS OF IDDS THERAPY. ASSESSMENT OF PHARMACOLOGICAL DATA AND COMPLICATIONS/SIDE EFFECTS WAS PERFORMED. THE AIM OF THIS STUDY WAS TO INVESTIGATE THROUGH A PROSPECTIVE APPROACH THE LONG-TERM EFFECTIVENESS OF IDDS TREATMENT. THE SAMPLE CONSISTED OF 10 FEMALES AND 10 MALES WITH AN AVERAGE AGE AT THE TIME OF LAST ASSESSMENT OF 60±1.98 YEARS. AT THE TIME THE STUDY WAS CARRIED OUT, 80% OF THE PATIENTS HAD ALREADY HAD THE DIAMORPHINE MEDICATION CONVERTED TO MORPHINE. IN INDIVIDUAL CASES, OTHER SUBSTANCES WERE ADDED TO THE INTRATHECAL MEDICATION, SUCH AS BUPIVACAINE (95%), CLONIDINE (75%), AND BACLOFEN (30%). PATIENTS' CASE NOTES WERE SCREENED FROM DATE OF IMPLANT TO (B)(6) 2010. REPORTABLE EVENT: THE AUTHORS REPORTED ONE CASE OF OVERDOSE (SECONDARY TO A CATHETER FRACTURE), ONE CASE OF RESPIRATORY DEPRESSION, TWO CASES OF PUMP POCKET INFECTION, EIGHT CASES OF PUMP RELATED FAILURES/REFILL DIFFICULTY, EIGHT CASES OF CATHETER KINKING/FRACTURES, 16 DEATHS (THE MAJORITY NOT DIRECTLY RELATED TO A KNOWN PHARMACOLOGICAL EFFECT OF THE OPIOID). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENTS AND OUTCOMES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death| R