BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3862827 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-23338
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 28, 2015
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 2 OF 2: REF MFR REPORT NUMBER 1627487-2014-23337. THE PT REPORTED SHE IS EXPERIENCING PAIN AT THE IPG SITE. THE PT STATED HER IPG IS LOCATED AT HER WAISTLINE AND WEARING PANTS IS PAINFUL. THE PAINT IS PRESENT WITH STIMULATION TURNED ON OR OFF. THE PT ALSO REPORTED OVERSTIMULATION AT THE LEAD SITE AND PAIN IN HER SIDE AND RIBCAGE. THE PT MAY UNDERGO SURGICAL INTERVENTION AT A FUTURE DATE TO ADDRESS THE REPORTED ISSUES.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-23337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309249 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3219 4103504

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: