BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1371529 · Received February 11, 2009

    Report

    Report Number
    2029203-2009-00259
    Event Type
    Malfunction
    Date Received
    February 11, 2009
    Date of Event
    December 18, 2009
    Report Date
    December 18, 2009
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING DIFFICULTY CHARGING HIS IPG. THE PHYSICIAN HAS RECOMMENDED THAT THE PATIENT'S IPG BE REPLACED. THE PATIENT DOES NOT WANT TO PROCEED WITH THE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention