BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3920362 · Received July 8, 2014

    Report

    Report Number
    3006630150-2014-01551
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE. THE PATIENT HAD LOST WEIGHT SINCE IMPLANT AND THE IPG HAD SHIFTED AS CONFIRMED BY X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING ISSUES WITH THE IPG SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING ISSUES WITH THE IPG SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397775 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention