BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3974015 · Received August 1, 2014

    Report

    Report Number
    3006630150-2014-01755
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG AS THE IPG WAS IMPLANTED TOO DEEP. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN THE PHYSICIAN OPENED UP THE POCKET, REMOVED A GOOD SIZED HEMATOMA THAT WAS SITTING ON THE FACE OF THE IPG, AND CLOSED UP THE POCKET. THE PHYSICIAN BELIEVED THAT HEMATOMA WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY AND THE CHARGING ISSUES HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450667 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention