BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 2113718 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-00755
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PT RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT SHE LOST FEELING AND MOVEMENT IN HER LOWER EXTREMITIES SHORTLY AFTER IMPLANT. FURTHER INTERROGATION REVEALED A HEMATOMA AT THE PT'S SURGERY SITE, TRACKING UP HER EPIDURAL SPACE. THE PT'S SCS SYSTEM WAS REMOVED AND A LEVEL THREE LAMINECTOMY WAS PERFORMED. FOLLOWING THE PROCEDURE, THE PT WAS SAID TO HAVE REGAINED 100% OF HER NEUROLOGICAL FUNCTION DESPITE EXPERIENCING PAIN FROM THE SURGERY. A F/U APPOINTMENT HAS BEEN SCHEDULED WITH THE IMPLANTING PHYSICIAN. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3252801

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R IMPLANTED:| SCS LEAD ANCHOR: MODEL: 1194| IMPLANTED:| SCS IPG: MODEL: 3788