BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2181343 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-01775
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. REFERENCE MFR REPORT: 1627487-2011-01774. THE PT (B)(6) RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S STIMULATION WAS NO LONGER EFFECTIVE. THE PHYSICIAN PERFORMED SURGERY AND NOTED ONE OF THE LEADS HAD MIGRATED. THE PT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE. F/U ON THE PT ON (B)(6) 2011 FOUND THAT HER AREA OF PAIN FEELS TETHERED. THE PHYSICIAN STATED THIS MAY BE RELATED TO SCAR TISSUE WHICH HAS ADHERED. THE PHYSICIAN PLANS TO PERFORM A HYDRODISSECTION AND RADIOFREQUENCY ABLATION PROCEDURE TO ADDRESS HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3153 2858057

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention