BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1923730 · Received December 9, 2010

    Report

    Report Number
    3006630150-2010-02045
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEADS WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S LEAD HAD PROTRUDED THROUGH THE SKIN. THE PHYSICIAN EXPLANTED THE LEAD AND THE PT WAS REPORTEDLY DOING FINE.

    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 65 YR Required Intervention ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET| MODEL#: SC-2218-50, SERIAL#: (B)(4)| MODEL#: SC-2218-70, SERIAL#: (B)(4)| MODEL#: SC-2218-50, SERIAL#: (B)(4)| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET