BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 8 LEAD

    MDR report key: 2001390 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-01157
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-01156. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 WHICH INCLUDED AN IPG AND A PADDLE LEAD PLACED OCCIPITALLY FOR OCCIPITAL NEURALGIA (OFF-LABEL). IT WAS REPORTED THAT THE PT WAS SEEN AT HER PAIN PHYSICIAN'S REQUEST TO SEE IF THE STIMULATION COVERAGE COULD BE INCREASED TO COVER A BROADER AREA OF HER LEFT LATERAL HEAD PAIN. IT WAS REPORTED THAT SHE HAD A SHARP PAIN SENSATION IN HER HEAD THAT WAS NOT ATTRIBUTED TO ANY SPECIFIC ACTIVITY OR MOVEMENT AND WOULD RESOLVE ITSELF. THE PT ALLEGEDLY EXPERIENCED A MILD SEIZURE WHILE IN THE PHYSICIAN OFFICE. IT WAS REPORTED THAT THESE EPISODES ARE BROUGHT ON BY INCREASED PAIN ON THE PT'S LEFT SIDE, AND THE PAIN PHYSICIAN REQUESTED THAT THE PT F/U WITH HER NEUROLOGIST. THE PT WAS REPROGRAMMED WITH AN IMPROVEMENT IN PAIN COVERAGE. THE PT ALSO REPORTED DIFFICULTY FULLY CHARGING HER IPG. SHE STATED THE CHARGER IMMEDIATELY SHOWS THE SYSTEM IS FULLY CHARGED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE PT WILL BE SEEN FOR A F/U APPOINTMENT TO EVALUATE THE CHARGING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 8 LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3280 2798899

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention