BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2981567 · Received February 27, 2013

    Report

    Report Number
    3006630150-2013-00325
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOSS OF STIMULATION. LEAD MIGRATION WAS CONFIRMED. DURING THE PROCEDURE, AN ADDITIONAL INFINION LEAD WAS IMPLANTED AND THE IPG WAS REPLACED WITH A SPECTRA TO ACHIEVE THE LEAD CONFIGURATION THE PHYSICIAN CHOSE TO USE TO RECAPTURE THE PATIENT'S TARGET AREA. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84538 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention