BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1943754 · Received December 21, 2010

    Report

    Report Number
    3006630150-2010-02194
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT HAD LOST HER STIMULATION. THE PHYSICIAN ASSESSED THE PT AND REPORTED THAT THE LEAD HAD MIGRATED, AND ONE OF THE ANCHORS HAD MIGRATED OUT OF THE INCISION. IN ADDITION, THE SECOND ANCHOR WAS EXPOSED THROUGH THE SKIN. THE INCISION IS IRRITATING THE PT BUT IS NOT INFECTED. THE PHYSICIAN HAD RECOMMENDED THE PT TO UNDERGO EXPLANT SURGERY.

    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 74 YR Required Intervention SERIAL # (B)(4)| MODEL # SC-2218-70| SERIAL # (B)(4)| MODEL # SC-1110-02| IPG KIT (WITHOUT PULL - THROUGH TUNNELER)| ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET