BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3899504 · Received June 27, 2014

    Report

    Report Number
    3006630150-2014-01454
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IPG WAS RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AND DISCOMFORT AT THE POCKET SITE. THE PATIENT WAS PRESCRIBED METHOCARBAMOL TO HELP WITH THE SWELLING. THE PATIENT WAS STILL EXPERIENCING DISCOMFORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AND DISCOMFORT AT THE POCKET SITE. THE PATIENT WAS PRESCRIBED METHOCARBAMOL TO HELP WITH THE SWELLING. THE PATIENT WAS STILL EXPERIENCING DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377474 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention