BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 88 LEAD, 60CM LENGTH

    MDR report key: 2093013 · Received April 14, 2011

    Report

    Report Number
    1627487-2011-00513
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-00512. THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND SURGICAL LEAD ON (B)(6) 2007. IT WAS REPORTED THAT THE RECHARGE BURDEN FOR HER IPG HAS INCREASED. IN ADDITION, THE PATIENT ALLEGES THAT HER STIMULATION IS NOT AS EFFECTIVE AS IT HAS BEEN IN THE PAST. ACCORDING TO THE MANUFACTURER'S RECORDS, A NEW CHARGING SYSTEM WAS RECENTLY SHIPPED TO THE PATIENT. AN APPOINTMENT HAS BEEN SCHEDULED FOR FURTHER INTERROGATION OF THE PATIENT'S SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3288 83665

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention