BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000972 · Received February 18, 2011

    Report

    Report Number
    3006630150-2011-00228
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED IPG REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING PAIN AT THE POCKET SITE. THE PHYSICIAN SUSPECTED THAT THE PATIENT MIGHT HAVE AN INFECTION. THE PHYSICIAN EXPLANTED THE PATIENT'S IPG. DURING THE EXPLANT, THE PHYSICIAN DIDN'T NOTE ANY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention