BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3052357 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-12436
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    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 1 OF 2. REFERENCE MFR REPORT NUMBER 1627487-2013-12437. IT WAS REPORTED FOLLOWING IPG REPLACEMENT, THE LEADS HAD INVALID IMPEDANCES. REPROGRAMMING GAINED ONLY MINIMAL STIMULATION COVERAGE. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE. NOTE THE PATIENT RECEIVED TWO LEADS FROM DIFFERENT LOT NUMBERS. BOTH LEADS ARE BEING REPORTED. ONE OF THE LEADS IS PLACED PERIPHERAL (OFF-LABEL USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137144 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 25852

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: