BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2921597 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-03101
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 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 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: 1627487-2013-03100. THE PATIENT RECEIVED 2 SCS LEADS WITH A DIFFERENT LOT NUMBERS. IT WAS REPORTED A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE PATIENT'S INEFFECTIVE STIMULATION ISSUE. X-RAYS IDENTIFIED THE PATIENT'S SCS LEAD HAD MIGRATED. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. FOLLOW-UP IDENTIFIED BOTH OF THE PATIENT'S SCS LEADS HAD MIGRATED. ADDITIONALLY, THE SCS LEADS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13982 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3314776

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3343| SCS IPG: MODEL 3788