BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A127 EXTENSION

    MDR report key: 2212641 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-05028
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K030461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 1 OF 2. REFERENCE MFR. REPORT #: 1627487-2011-05029. THE PATIENT RECEIVED HER SCS IPG ON (B)(6) 2005 ALONG WITH TWO LEAD EXTENSIONS. THE PATIENT ALSO HAD TWO MEDTRONIC LEADS. IT WAS REPORTED THAT THE PATIENT'S SCS SYSTEM WAS EXPLANTED AND REPLACED DUE TO INEFFECTIVE STIMULATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A127 EXTENSION SPINAL CORD STIMULATION LEAD EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 2342 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT:| SCS IPG: MODEL: 3716