BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2925902 · Received January 22, 2013

    Report

    Report Number
    3006630150-2013-00125
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    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 THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS DECIDED NOT TO PROCEED WITH THE REVISION. NO FURTHER COURSE OF ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS NOT PROVIDING STIMULATION. THE POCKET MOVED TO AN ANGLE, SIDEWAYS. THE PATIENT WILL UNDERGO POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS NOT PROVIDING STIMULATION. THE POCKET MOVED TO AN ANGLE, SIDEWAYS. THE PATIENT WILL UNDERGO POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS NOT PROVIDING STIMULATION. THE POCKET MOVED TO AN ANGLE, SIDEWAYS. THE PATIENT WILL UNDERGO POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS NOT PROVIDING STIMULATION. THE POCKET MOVED TO AN ANGLE, SIDEWAYS. THE PATIENT WILL UNDERGO POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31210 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention