BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PISCES-QUAD

    MDR report key: 920864 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03022
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    June 5, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K881491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS BEING FILED.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KHAN, Y ET AL. "APPLICATION OF SPINAL CORD STIMULATION FOR THE TREATMENT OF ABDOMINAL VISCERAL PAIN SYNDROMES: CASE REPORTS." NEUROMODULATION, VOLUME 8, NUMBER 1, 2005 14-27. THE ARTICLE DISCUSSED NINE PATIENTS, EXPERIENCING ABDOMINAL VISCERAL PAIN DUE TO VARIOUS CONDITIONS INCLUDING CHRONIC NONALCOHOLIC PANCREATITIS, POST-TRAUMATIC SPLENECTOMY, AND GENERALIZED ABDOMINAL PAIN SECONDARY TO LAPAROTOMIES, WERE TREATED WITH SCS. REPORTABLE EVENT: 3487A LEAD (N=1) - ONE PATIENT WITH CHRONIC PANCREATITIS BEING TREATED WITH SCS FOR VISCERAL PAIN EXPERIENCED A DECREASE IN PAIN RELIEF WITH PARETHESIAS NOW OBSERVED IN THE LOWER EXTREMITIES. LEAD MIGRATION WAS CONFIRMED BY X-RAY AND THE LEAD WAS REPOSITIONED AND PATIENT WAS RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES-QUAD GZB MEDTRONIC NEUROMODULATION 3487A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R