BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3202539 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01403
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT PROCEED WITH THE POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DISCOMFORT DURING CHARGING DUE TO THE POSITION OF THE IPG AT THE SITE. THE PATIENT ALSO FELT WARMTH WHEN CHARGING. THE PATIENT WILL UNDERGO AN IPG REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DISCOMFORT DURING CHARGING DUE TO THE POSITION OF THE IPG AT THE SITE. THE PATIENT ALSO FELT WARMTH WHEN CHARGING. THE PATIENT WILL UNDERGO AN IPG REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302821 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention