BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3252180 · Received July 29, 2013

    Report

    Report Number
    3006630150-2013-01576
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 A REVISION PROCEDURE WHEREIN THE POCKET SITE WAS MADE DEEPER. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE DISCOMFORT WAS CAUSED BY THE IPG BEING TOO SHALLOW. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE DISCOMFORT WAS CAUSED BY THE IPG BEING TOO SHALLOW. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE DISCOMFORT WAS CAUSED BY THE IPG BEING TOO SHALLOW. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352589 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention