BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2780341 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-03466
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    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 1 OF 2. THE PT RECEIVED 2 SCS LEADS WITH DIFFERENT LOT NUMBERS. REFERENCE MFR REPORT: 1627487-2012-03467. IT WAS REPORTED THE PT IS NOT RECEIVING STIMULATION IN HER RIGHT LEG DUE TO MALPOSITION OF THE SCS LEAD DURING IMPLANTATION. SUBSEQUENTLY, THE SCS LEAD WAS TURNED OFF. THE PHYSICIAN IS PLANNING ON REFERRING THE PT TO A NEURO-SURGEON FOR SURGICAL INTERVENTION. THERE IS NO ADDITIONAL INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 3511223

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)