BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1016257 · Received March 19, 2008

    Report

    Report Number
    2029203-2008-00162
    Event Type
    Injury
    Date Received
    March 19, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ADVANCED SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCT WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A LEAD PLACEMENT PROCEDURE, IT WAS CONFIRMED THAT THE PT HAD A DURA PUNCTURE. THE PHYSICIAN ABORTED THE PROCEDURE. THE PT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW ADVANCED SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R