BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1953748 · Received January 4, 2011

    Report

    Report Number
    3006630150-2010-02232
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL AND PERFORMANCE TESTS PERFORMED. NO ANOMALIES WERE NOTED WITH THE DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S IPG WAS REPLACED DURING A LEAD IMPLANT PROCEDURE. THE PHYSICIAN DECIDED TO REPLACE THE IPG AS A PRECAUTION DUE TO MONOPOLAR ELECTROCAUTERY WAS USED DURING A PREVIOUS REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS REPLACED DURING A LEAD IMPLANT PROCEDURE. THE PHYSICIAN DECIDED TO REPLACE THE IPG AS A PRECAUTION DUE TO MONOPOLAR ELECTROCAUTERY WAS USED DURING A PREVIOUS REVISION 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