BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3092746 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01531
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    May 25, 2012
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    JACKSON, T. P., LONERGAN, D. F., TODD, R. D., MARTIN, P. R. INTENTIONAL INTRATHECAL OPIOID DETOXIFICATION IN 3 PATIENTS: CHARACTERIZATION OF THE INTRATHECAL OPIOID WITHDRAWAL SYNDROME. PAIN PRACTICE : THE OFFICIAL JOURNAL OF WORLD INSTITUTE OF PAIN. 2013;13(4):297-309. DOI: 10.1111/J.1533-2500.2012.00584.X. SUMMARY: THREE PATIENTS WITH INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS), INADEQUATE PAIN CONTROL, AND DECLINING FUNCTIONALITY UNDERWENT ABRUPT IT OPIOID CESSATION. THIS WAS ACCOMPLISHED THROUGH A STANDARDIZED PROTOCOL WITH SYMPTOM-TRIGGERED ADMINISTRATION OF CLONIDINE AND BUPRENORPHINE, MONITORED USING THE CLINICAL OPIATE WITHDRAWAL SCALE. REPORTED EVENT: A (B)(6) WOMAN UNDERWENT IMPLANTATION OF A SPINAL CORD STIMULATOR IN 2002. ALTHOUGH THIS HELPED INITIALLY, HER PAIN PROGRESSED AND ORAL METHADONE AND HYDROMORPHONE WERE INITIATED AND ESCALATED. WITH DOSE ESCALATION, THE PATIENT BEGAN TO HAVE INTOLERABLE SIDE EFFECTS AND AN IDDS WAS PLACED IN (B)(6) 2008. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194297 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention