BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C LEAD, 60CM

    MDR report key: 1971522 · Received January 21, 2011

    Report

    Report Number
    1627487-2011-00129
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: AS RECEIVED, THE PHYSICAL DIMENSIONS OF THE DEVICE ARE WITHIN PUBLISHED RANGES. THE LEAD ALSO PASSED ALL FUNCTIONAL 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00130. THE PATIENT WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS EXPERIENCING PAIN IN HER RIGHT RIB CAGE. A CT SCAN WAS TAKEN WHICH REVEALED THAT THE LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2010 TO REPOSITION THE DEVICE. THE FOLLOWING DAY, THE PATIENT REPORTED THAT SHE WAS NOW EXPERIENCING PAIN IN HER RIGHT RIB. IN AN EFFORT TO RESOLVE THIS MATTER, THE PHYSICAL REMOVED THE ORIGINAL LEAD AND REPLACED IT WITH DIFFERENT MODEL. A PORT PLUG WAS INSERTED INTO THE UNUSED HEADER OF THE IPG. IT WAS LATER DISCOVERED HOWEVER THAT THE SHELF LIFE OF THE PORT PLUG HAD EXPIRED PRIOR TO IMPLANT. FOLLOW-UP ON THE PATIENT FOUND THAT THE REPORTED DISCOMFORT HAS SUBSIDED SINCE THE LEAD REPLACEMENT. THE EXPLANTED LEAD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PORT PLUG REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C LEAD, 60CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3214 3071779

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention