BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 4801896 · Received May 28, 2015

    Report

    Report Number
    1627487-2015-07256
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    June 30, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 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

    (B)(4). 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 2 OF 2. REFERENCE MFR REPORT #: 1627487-2015-07255.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT #: (B)(4).

    Description of Event or Problem · 1

    DEVICE 2 OF 2REFERENCE MFR REPORT #: 1627487-2015-07255

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346106 LAMITRODE TRIPOLE 16 LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 4245475

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL: 3386, SCS EXTENSION