BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2990551 · Received March 5, 2013

    Report

    Report Number
    3006630150-2013-00362
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION WILL BE PROVIDED TO BSN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR STLEAD, 50CM MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOR CHRONIC NECK PAIN AND UNCONTROLLED TWITCHING AND UNDERWENT AN EXPLANT PROCEDURE. THE REASON FOR THE EXPLANT, NECK PAIN AND UNCONTROLLED TWITCHING IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOR CHRONIC NECK PAIN AND UNCONTROLLED TWITCHING AND UNDERWENT AN EXPLANT PROCEDURE. THE REASON FOR THE EXPLANT, NECK PAIN AND UNCONTROLLED TWITCHING IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93685 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention