BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4112228 · Received September 23, 2014

    Report

    Report Number
    3006630150-2014-02154
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THREE OF THE FOUR SET SCREWS WERE UNSCREWED FROM THE CONNECTOR BLOCK ASSEMBLY. THE OTHER SETSCREW FOR PORT A WAS NOT IN THE CONNECTOR BLOCK, AND NOT RETURNED FOR ANALYSIS. WHEN THE SET SCREWS WERE PUT BACK INTO THE CONNECTOR BLOCKS, THEY LOCKED INTO A TEST LEAD WITHOUT ANY ANOMALIES AND THEY EXHIBITED NORMAL DEVICE CHARACTERISTICS. REVIEW OF THE DHR DID NOT INDICATE ANY ANOMALY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT X-RAY WAS TAKEN AND SHOWED THAT NO DEVICE WAS LEFT INSIDE THE PATIENT'S BODY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING DEVICE ANALYSIS VISUAL INSPECTION REVEALED THAT THREE OF THE FOUR SET SCREWS WERE UNSCREWED FROM THE CONNECTOR BLOCK ASSEMBLY. THE OTHER SETSCREW FOR PORT A WAS NOT IN THE CONNECTOR BLOCK, AND NOT RETURNED FOR ANALYSIS. IT WAS NOT KNOWN IF IT WAS LEFT INSIDE THE PATIENT¿S BODY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING DEVICE ANALYSIS VISUAL INSPECTION REVEALED THAT THREE OF THE FOUR SET SCREWS WERE UNSCREWED FROM THE CONNECTOR BLOCK ASSEMBLY. THE OTHER SETSCREW FOR PORT A WAS NOT IN THE CONNECTOR BLOCK, AND NOT RETURNED FOR ANALYSIS. IT WAS NOT KNOWN IF IT WAS LEFT INSIDE THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592464 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention