BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3130613 · Received May 24, 2013

    Report

    Report Number
    3007566237-2013-01742
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 1, 2007
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: UNK, SERIAL/LOT# :UNK. (B)(4).

    Description of Event or Problem · 1

    HAYES, C., JORDAN, M. S., HODSON, F. J., RITCHARD, L. CEASING INTRATHECAL THERAPY IN CHRONIC NON-CANCER PAIN: AN INVITATION TO SHIFT FROM BIOMEDICAL FOCUS TO ACTIVE MANAGEMENT. PLOS ONE. 2012;7(11). DOI: 10.1371/JOURNAL.PONE.0049124. SUMMARY: THIS CASE SERIES REPORTS THE CHANGING USE OF IT IMPLANTED DRUG DELIVERY SYSTEMS (IDDSS) FOR CHRONIC NON-CANCER PAIN OVER 13 YEARS. INITIALLY IT THERAPY WAS USED SELECTIVELY FOLLOWING MULTIDISCIPLINARY ASSESSMENT AND DOUBLE BLIND IT TRIAL. TYPICAL THERAPY COMBINED OPIOID WITH CLONIDINE. MULTIDIMENSIONAL MANAGEMENT WAS OFFERED. TREATMENT STRATEGY CHANGED IN 2003 DUE TO HIPS EXPERIENCE OF LIMITED THERAPEUTIC GAINS AND EQUIVOCAL SUPPORT FOR IT THERAPY IN THE LITERATURE. SUBSEQUENTLY IT THERAPY WAS NO LONGER INITIATED FOR NON-CANCER PAIN AND THOSE ON ESTABLISHED REGIMES WERE ENCOURAGED TO SHIFT TO ORAL/TRANSDERMAL OPIOIDS WITH GREATER EMPHASIS ON ACTIVE MANAGEMENT. PATIENT EDUCATION AND CONSULTATION WERE KEY ELEMENTS. WHERE IT CESSATION WAS ELECTIVE GRADUAL DOSE REDUCTION COMMENCED AS AN OUTPATIENT. IN ELECTIVE AND URGENT CASES KETAMINE INFUSION AND ORAL CLONIDINE WERE USED DURING HOSPITAL ADMISSIONS TO COVER THE SWITCH TO ORAL/TRANSDERMAL OPIOIDS. OVER THE STUDY PERIOD TRANSITION OCCURRED TO A BROADER MANAGEMENT FRAMEWORK IN WHICH IT THERAPY FOR CHRONIC NON-CANCER PAIN WAS NO LONGER SUPPORTED BY HIPS. 25 PATIENTS WERE MANAGED USING IDDSS; 8 IMPLANTED BY HIPS AND 17 BY OTHER TEAMS. DOSE ESCALATION AND ADVERSE EFFECTS WERE COMMON. 24 OF 25 PATIENTS CEASED IT THERAPY; 7 (29%) WITH URGENT IDDS RELATED COMPLICATIONS, 16 (67%) ELECTIVELY AND 1 DUE TO AN UNRELATED DEATH. THE REMAINING PATIENT RETURNED TO HER ORIGINAL TEAM TO CONTINUE IT THERAPY. ONE POST-EXPLANTATION PATIENT TRANSFERRED TO ANOTHER TEAM TO RECOMMENCE IT THERAPY. THE REMAINDER WERE SUCCESSFULLY MAINTAINED ON ORAL/TRANSDERMAL OPIOIDS COMBINED WITH ACTIVE MANAGEMENT. PLEASE NOTE-THIS PATIENT WAS PREVIOUSLY REPORTED WITH LIMITED INFORMATION ON MANUFACTURER REPORT 3007566237-2013-00338. REPORTED EVENT: IT THERAPY WAS CEASED ABRUPTLY IN TWO PATIENTS DUE TO SEVERE INFECTION REQUIRING PUMP REMOVAL. FOLLOW-UP RECEIVED FROM CORRESPONDING AUTHOR: ONE OF THESE PATIENTS, MRN 0764886, HAD THE INFECTED PUMP EXPLANTED IN 2007. HE WAS TRANSFERRED TO THE PRIVATE SECTOR IN 2009 TO RECOMMENCE IT THERAPY. THE OTHER PATIENT THAT EXPERIENCED INFECTION, MRN 0168925, HAS BEEN CAPTURED UNDER MANUFACTURER REPORT 3007566237-2013-00338-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231500 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention