BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC CONVENTIONAL IPG

    MDR report key: 2000816 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-01151
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORTS: 1627487-2011-01152 AND 1627487-2011-01153. THE PATIENT RECEIVED HIS SCS SYSTEMS, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT REQUESTED THE SYSTEM BE REMOVED DUE TO INEFFECTIVE STIMULATION. IT WAS REPORTED THAT INCREASING THE AMPLITUDE DID NOT RESOLVE THE ISSUE BUT INSTEAD GRADUALLY MADE THE PAIN WORSE. THE PHYSICIAN EXPLANTED THE SYSTEM ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIV. 3688 2872096

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention