BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30 CM WIDE-SPACED QUATTRODE LEAD

    MDR report key: 2230801 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-07092
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT 1627487-2011-07112. THE PT RECEIVED A SCS SYSTEM MON (B)(6) 2011. CONSISTING OF 2 LEADS FROM TWO DIFFERENT LOTS. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT HAS STIMULATION BUT WANTED STIM IN THEIR LEFT LATERAL THIGH. X-RAY OF PT SHOWED THAT BOTH LEADS HAVE MIGRATED SLIGHTLY. THE PT SAID THAT THIS IS HIS AREA OF PAIN AND WILL MONITOR FOR ANY CHANGED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30 CM WIDE-SPACED QUATTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 3301964

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: