BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2153370 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-00902
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE INFORMATION WAS PROVIDED FOR THE EXPLANTED LEADS; THEREFORE, THE MODEL AND LOT NUMBERS AS WELL AS THE IMPLANT, MANUFACTURING AND EXPIRATION DATES ARE UNKNOWN. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00901. THE PATIENT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION, AND HER LEAD AND EXTENSION WERE EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL UNKNOWN| IMPLANTED: