BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2925897 · Received January 22, 2013

    Report

    Report Number
    3006630150-2013-00127
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. CHARGE PROFILE REVEALED VARIOUS TIMES OF ERRATIC COUPLING/POOR ALIGNMENT OF THE CHARGER TO THE IPG. THE CHARGE CURRENT SOMETIMES REACHED THE MAXIMUM, AND INDICATES GOOD ALIGNMENT, BUT THIS OPTIMAL ALIGNMENT WAS NOT CONSISTENT. THE REASON FOR THE ERRATIC COUPLING WAS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE WHICH WAS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITED NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. IMPEDANCE READINGS WERE WITHIN THE NORMAL RANGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION, DURING WHICH, THE IPG WAS REPLACED SO IMPEDANCES COULD BE CHECKED. THERE WAS NO DEVICE MALFUNCTION SUSPECTED. THE IPG WAS REPOSITIONED TO ANOTHER LOCATION PER PATIENT'S PREFERENCE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A HARD TIME CHARGING HER IPG DUE TO THE IPG BEING FLIPPED. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING HER IPG AS HER IPG WAS DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED THAT THE IPG MAY BE FLIPPED. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A HARD TIME CHARGING HER IPG DUE TO THE IPG BEING FLIPPED. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING HER IPG AS HER IPG WAS DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED THAT THE IPG MAY BE FLIPPED. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30321 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention