BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2071100 · Received April 27, 2011

    Report

    Report Number
    3006630150-2011-00615
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL COMPLICATION WAS OBSERVED WHILE PREPING THE PATIENT FOR THE SURGERY. NO BSN PRODUCTS WERE EVEN OPENED AND/OR USED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: N/A.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IMPLANT SURGERY WAS CANCELLED DUE TO COMPLICATIONS CAUSED BY THE ANESTHESIA. THE PATIENT EXPERIENCED RIGHT ARM PARALYSIS. NOTHING WAS IMPLANTED AND NO INCISIONS WERE MADE. THE PHYSICIAN CANCELLED THE SURGERY AND ADVISED THE PATIENT THAT HE WAS NOT A SURGICAL CANDIDATE AT THIS TIME. THE PATIENT HAS REGAINED SENSATION IN HIS RIGHT ARM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IMPLANT SURGERY WAS CANCELLED DUE TO COMPLICATIONS CAUSED BY THE ANESTHESIA. THE PATIENT EXPERIENCED RIGHT ARM PARALYSIS. NOTHING WAS IMPLANTED AND NO INCISIONS WERE MADE. THE PHYSICIAN CANCELLED THE SURGERY AND ADVISED THE PATIENT THAT HE WAS NOT A SURGICAL CANDIDATE AT THIS TIME. THE PATIENT HAS REGAINED SENSATION IN HIS RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R