BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2092889 · Received May 11, 2011

    Report

    Report Number
    1627487-2011-01512
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    THE PT ((B)(6)) REC'D HIS SCS TRIAL SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT INTRAOPERATIVE TESTING REVEALED HIGH IMPEDANCE READINGS ON LEAD CONTACTS, AND STIMULATION COULD NOT BE ACHIEVED. THE PHYSICIAN REPLACED THE LEAD WITH A LEAD OF THE SAME LOT NUMBER. IT WAS REPORTED THAT THE PT WAS PROGRAMMED POSTOPERATIVE, AND HE REPORTED AN UNCOMFORTABLE PRESSURE AND NO PARESTHESIA. PARESTHESIA WAS EVENTUALLY OBTAINED DURING PROGRAMMING, BUT THE UNCOMFORTABLE PRESSURE ALLEGEDLY REMAINED. THE PHYSICIAN EXPLANTED THE LEAD ON DAY 4 OF THE TRIAL DUE TO THE PT FEELING ILL AND REPORTING NO PAIN RELIEF. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3086 3269330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention