BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1936076 · Received December 13, 2010

    Report

    Report Number
    3006630150-2010-02062
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS PERFORMED. THE COMPLAINT OF THE IPG DEPLETING RAPIDLY WAS CONFIRMED IT WAS DETERMINED THAT THIS SLIGHTLY HIGHER THAN NORMAL CURRENT DRAIN WAS FROM THE ANALOG/DIGITAL IC SECTION OF THE IPG ELECTRONICS. IT COULD NOT BE DETERMINED CONCLUSIVELY, WHICH IC IS THE ROOT CAUSE OF THE FAILURE AS BOTH COMPONENTS ARE COVERED IN GLOP TOP WHICH MAKES TEST POINTS INACCESSIBLE AND TROUBLESHOOTING TO A SPECIFIC COMPONENT LEVEL IS NOT POSSIBLE. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A RECENTLY IMPLANTED PATIENT DEVELOPED EDEMA AT THE IMPLANT SITE. THE PATIENT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. THE PATIENT ALSO REPORTED THAT THE IPG IS DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT SURGERY WAS RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A RECENTLY IMPLANTED PT DEVELOPED EDEMA AT THE IMPLANT SITE. THE PT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. THE PT ALSO REPORTED THAT THE IPG IS DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE PT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT SURGERY WAS RECOMMENDED.

    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 57 YR Required Intervention