BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3012176 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-12342
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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. REF MFR REPORT: 1627487-2013-12341. IT WAS REPORTED THE PT LOST STIMULATION. THE SJM REP INTERROGATED THE SYSTEM AND FOUND INVALID IMPEDANCES. THE PHYSICIAN PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE. NOTE THE PT RECEIVED TWO LEADS FROM DIFFERENT LOT NUMBERS, BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106526 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 27311

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3342| SCS IPG: MODEL 3688