BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1864511 · Received October 6, 2010

    Report

    Report Number
    3006630150-2010-01680
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS DISCARDED AND WILL NOT BE RETURNED TO BSN FOR EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PERMANENT IMPLANT PROCEDURE WHILE THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND LEAD THE PT SCREAMED OUT IN PAIN AND THE REST OF THE PROCEDURE WAS ABORTED. THE PT WAS GIVEN PAIN MEDICATION AND WAS REPORTEDLY DOING FINE AFTER THE IMPLANT PROCEDURE. THE PHYSICIAN BELIEVES THERE COULD HAVE BEEN SOME INFLAMMATION THAT MAY HAVE CAUSED THE PT SOME PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET| SERIAL# (B)(4)| MODEL# SC-2218-70