BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3870866 · Received June 12, 2014

    Report

    Report Number
    3006630150-2014-01306
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING AN IPG REVISION (MFR REPORT#3006630150-2014-01114), THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT ANOTHER REVISION WHERE THE IPG SITE WAS REVISED. THE PATIENT IS DOING WELL AND IS ABLE TO CHARGE NOW.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING AN IPG REVISION (MFR REPORT#3006630150-2014-01114), THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT ANOTHER REVISION WHERE THE IPG SITE WAS REVISED. THE PATIENT IS DOING WELL AND IS ABLE TO CHARGE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347139 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention