BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2091627 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01454
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K000852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HEADACHES WHILE THE STIMULATION WAS TURNED ON. SHE STATED THAT SHE TURNED OFF HER STIMULATION AND THE HEADACHES IMPROVED; HOWEVER, THE HEADACHES RETURNED WHEN STIMULATION WAS TURNED BACK ON. THE PATIENT IS SCHEDULED TO MEET WITH HER PHYSICIAN TO ADDRESS THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3143 3205903

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR IMPLANTED:| SCS IPG: MODEL 3788