BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5499217 · Received March 14, 2016

    Report

    Report Number
    3007566237-2016-01380
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    January 1, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. (B)(4).

    Description of Event or Problem · 1

    KASHY, B.K., ABD-ELSAYED, A.A., FARAG, E., YARED, M., VAKILI, R., ESA, W.A.S. AMPUTATION AS AN UNUSUAL TREATMENT FOR THERAPY-RESISTANT COMPLEX REGIONAL PAIN SYNDROME, TYPE 1. OCHSNER JOURNAL. 2015;15(4):441-442. DOI: 10.1043/TOJ-14-0074. SUMMARY: COMPLEX REGIONAL PAIN SYNDROME, TYPE 1 (CRPS-1) CAUSES SEVERE PAIN THAT CAN BE RESISTANT TO MULTIPLE TREATMENT MODALITIES. AMPUTATION AS A FORM OF LONG-TERM TREATMENT FOR THERAPY-RESISTANT CRPS-1 IS CONTROVERSIAL. REPORTED EVENT: A (B)(6) MAN WITH COMPLEX REGIONAL PAIN SYNDROME TYPE 1 (CRPS-1) REPORTEDLY FAILED ALL TREATMENT MODALITIES, INCLUDING SPINAL CORD STIMULATION (SCS) WHICH WAS IMPLANTED IN 2010 AND REMOVED IN 2012. IT WAS NOTED THAT THE PATIENT LATER UNDERWENT BELOW-THE-KNEE AMPUTATION, RESULTING IN A ¿FAVORABLE OUTCOME.¿ FOLLOW-UP TO THE ARTICLE¿S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR PATIENT/DEVICE INFO, EVENT DATES, SYMPTOMS, DIAGNOSTICS/TROUBLESHOOTING, AND POTENTIAL CAUSES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155187 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention