BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1871056 · Received October 12, 2010

    Report

    Report Number
    3006630150-2010-01752
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S IPG WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PT'S SYMPTOMS WERE PAIN AND SWELLING. THE PT WAS PLACED ON ORAL AND IV ANTIBIOTICS AND AN ANTIBIOTIC SPACER WAS PLACED INSIDE THE POCKET. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS DEVICE RELATED. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    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 UNK Required Intervention