BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2792005 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-03526
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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 3. REFERENCE MFR REPORTS: 1627487-2012-03527 AND 1627487-2012-03528. THE PT RECEIVED 4 SCS LEADS, 2 WITH DIFFERENT LOT NUMBERS AND 2 WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. A SJM REP WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. X-RAYS SHOWED 2 OF THE SCS LEADS HAVE MIGRATED. A SJM WAS UNABLE TO GAIN EFFECTIVE STIMULATION WITH A SECOND REPROGRAMMING. THE PHYSICIAN PLANS ON TAKING SURGICAL INTERVENTION TO RESOLVE THE ISSUE. F/U IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3554353

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3688| IMPLANT:| IMPLANT:| SCS EXTENSION: MODEL 3341 (2)