BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3960632 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-24041
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 17, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED AUTO-REDUCTION DIAGNOSTICS INDICATED MULTIPLE INVALID LEAD IMPEDANCES. X-RAYS DID NOT REVEAL ANY ANOMALIES. AS PER SJM REPRESENTATIVE, THE PATIENT CONTINUES TO LOSE STIMULATION DUE TO INVALID IMPEDANCES. THE PATIENT WILL CONSULT THE SURGEON TO ADDRESS ISSUES.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED THE PATIENT WILL HAVE HIS SCS SYSTEM REMOVED. ADDITIONAL FOLLOW-UP IDENTIFIED THE PATIENT'S SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426582 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3071780

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT: