BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3033912 · Received April 3, 2013

    Report

    Report Number
    3006630150-2013-00606
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 7, 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 UNDERGO A POCKET REVISION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT POCKET REVISION DUE TO DISCOMFORT AT THE POCKET SITE BECAUSE OF THE IPG¿S POSITION. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION WHEREIN THE IPG WILL BE RELOCATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION WHEREIN THE IPG WILL BE RELOCATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION WHEREIN THE IPG WILL BE RELOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137179 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention