BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2984191 · Received February 28, 2013

    Report

    Report Number
    3006630150-2013-00370
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-70 SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM,

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SEVERE ABDOMINAL PAIN FOLLOWING A PERMANENT IMPLANT PROCEDURE. THE PHYSICIAN SUSPECTED THAT THIS MIGHT HAVE BEEN DUE TO THE NUMEROUS ATTEMPTS OF INSERTING THE PADDLE LEAD CAUSING A NERVE TO BE HIT AND AFFECTED. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS. THE PATIENT WAS REPORTEDLY DOING WELL AFTER HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86088 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R