BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3031943 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15425
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15424. IT WAS REPORTED THE PT EXPERIENCES A SHARP PINCHING/BURNING SENSATION AT HER IPG SITE WHILE STIMULATION IS OFF. ADDITIONALLY, ONE INSTANCE OF THE SENSATION OCCURRED WHILE THE PT WAS ASLEEP WITH STIMULATION OFF AND WOKE HER UP. THE PT STATED SHE DOES NOT FEEL THE SENSATION WHEN CHARGING. THE PT STATED SHE HAS ALSO EXPERIENCED THE SENSATION ONCE WHEN THE STIMULATION WAS ON. THE PT INDICATES THE SENSATIONS LAST ABOUT 30-60 SECONDS. THE IPG SITE IS NOT WARM TO THE TOUCH. THE NURSE PRACTITIONER STATED THE POCKET SITE LOOKED FINE. THE SJM REP IS TO MEET WITH THE PT FOR REPROGRAMMING AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128468 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3571596

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention