BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4570959 · Received March 4, 2015

    Report

    Report Number
    3006630150-2015-00545
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 16, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AT THE GENERATOR SITE. THE IPG SITE WAS DRAINED. THE PHYSICIAN DID NOT SUSPECT INFECTION BUT ANTIBIOTICS WERE PRESCRIBED. THE SWELLING WAS RESOLVED. NO FURTHER COURSE OF ACTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AT THE GENERATOR SITE. THE PATIENT WAS SEEN TWICE TO GET THE POCKET SITE DRAINED. THE PHYSICIAN DID NOT SUSPECT INFECTION BUT ANTIBIOTICS WERE PRESCRIBED. THE SWELLING WAS RESOLVED. NO FURTHER COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150311 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention