BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2892882 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-15119
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 10, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICLA - NEUROMODULATION
    Product Code
    GZB
    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 INFORMATION 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: 1627487-2012-15118. IT WAS REPORTED THE PT HAD HER SCS SYSTEM EXPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICLA - NEUROMODULATION 3219 2749567

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention