BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION ®

    MDR report key: 2761312 · Received September 26, 2012

    Report

    Report Number
    3006630150-2012-01716
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE ANALYSIS INDICATES THAT THE IPG PASSED ALL VISUAL, ELECTRICAL, PERFORMANCE, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. THE CHARGE PROFILE REVEALED THE CHARGING ATTEMPT MADE PRIOR TO RECEIPT OF THE DEVICE IN THE LAB EXHIBITED POOR COUPLING OF THE CHARGER TO THE IPG. OTHER PORTIONS OF THE CHARGE PROFILE GRAPH ILLUSTRATE CHARGE CURRENT WAS ABLE TO REACH THE MAXIMUM CURRENT, AND INDICATES GOOD ALIGNMENT. THE REASON FOR THE POOR COUPLING IS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A SHOOTING SENSATION DOWN HER LEG WITH THE STIMULATION OFF AND HAD DIFFICULTY CHARGING THE IMPLANT. THE DECISION WAS MADE TO REVISE THE PATIENT'S POCKET SITE AND TO REPLACE THE IPG. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A SHOOTING SENSATION DOWN HER LEG WITH THE STIMULATION OFF AND HAD DIFFICULTY CHARGING THE IMPLANT. THE DECISION WAS MADE TO REVISE THE PATIENT'S POCKET SITE AND TO REPLACE THE IPG. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.

    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 44 YR Required Intervention