BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1990668 · Received February 8, 2011

    Report

    Report Number
    3006630150-2011-00194
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE REASON FOR EXPLANT WAS THAT THE PATIENT "JUST WANTED IT OUT". THE PATIENT REQUESTED TO BE ONLY TREATED WITH NARCOTICS. THE DEVICE WAS WORKING PROPERLY AND THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE. THE DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION® SYSTEM WILL BE EXPLANTED. THE REASON FOR THE EXPLANT AND THE DATE OF THE PROCEDURE ARE UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S PRECISION SYS WILL BE EXPLANTED. THE REASON FOR THE EXPLANT AND THE DATE OF THE PROCEDURE ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention (B)(4)| MODEL # SC-2158-50| LINEAR LEAD, 50 CM WITH PRE-LOADED 0.014" STYLET| (B)(4)