BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3914466 · Received July 3, 2014

    Report

    Report Number
    3006630150-2014-01520
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICE COMPONENTS INVOLVED: MODEL#: SC-2208-50, SERIAL#: (B)(4), DESCRIPTION:ST LINEAR LEAD 50CM. MODEL#: SC-3138-55, SERIAL#: (B)(4), DESCRIPTION: SCS PHIII EXT 55CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390017 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention