BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 2063276 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-01291
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED AN SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT HAD UNDERGONE A REVISION FOR LEAD MIGRATION ON (B)(6) 2010, AND EFFECTIVE STIMULATION WAS CAPTURED POSTOPERATIVE. IT WAS REPORTED THAT ON (B)(6) 2010, THE PT'S LEAD EXHIBITED INVALID AND LOW IMPEDANCE READINGS. THE PT ALLEGEDLY COULD NOT FEEL STIMULATION. AS OF (B)(6) 2011, THE PT STILL DID NOT HAVE STIMULATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIV. 3608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention