BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 2033522 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-01302
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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

    THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF LEAD MIGRATION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN SCS SYSTEM WHICH INCLUDED A SURGICAL LEAD ON (B)(6) 2009 AND AN IPG ON (B)(6) 2009 FOR BILATERAL ARM PAIN. IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION TO HER LEFT SIDE. AN X-RAY SHOWED THAT THE LEAD HAD MIGRATED TO THE RIGHT. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD WITH A DIFFERENT MODEL SURGICAL LEAD ON (B)(6) 2011. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE. NO FURTHER PATIENT ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3219 2749567

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention