BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD

    MDR report key: 2023252 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-01242
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 MANUFACTURER REPORT: 1627487-2011-01241. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND PADDLE LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT EXPERIENCED WEAKNESS IN HIS LEGS THAT CAUSED HIM TO COLLAPSE TWICE. HE STATED THAT HE FELT TOO WEAK TO SUPPORT HIS OWN WEIGHT. DURING A REPROGRAMMING SESSION, THE PT EXPERIENCED EXTREMELY PAINFUL STIMULATION WHEN HE TRIED LAYING FLAT. HE ALLEGEDLY DID NOT FEEL THE PAINFUL STIMULATION WHEN HE LEANED TO HIS SIDE AT A 30 DEGREE ANGLE. THE PHYSICIAN FELT THAT THE PADDLE LEAD MIGHT BE IRRITATING THE SPINAL CORD/NERVE ROOT. FOLLOW UP ON THE PT FOUND THAT HE STILL CONTINUED TO HAVE THE SHARP PAIN WITH THE STIMULATION OFF. THE PHYSICIAN DECIDED TO EXPLANT THE SYSTEM ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3219 3252801

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention