BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 3960426 · Received July 17, 2014

    Report

    Report Number
    1627487-2014-26568
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    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.

    Description of Event or Problem · 1

    THE PATIENT HAS TWO OCCIPITAL LEADS (FOR OFF-LABEL USE) FROM THE UNKNOWN LOT NUMBER. IT WAS REPORTED THE PATIENT LOST STIMULATION TO HER LEFT SIDE. DIAGNOSTIC TESTING INDICATED INVALID IMPEDANCE READINGS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND 1 LEAD WAS FOUND TO BE COILED DOWN AROUND THE IPG. THE LEAD WAS SHEARED AND TORN. THE LEAD WAS EXPLANTED AND REPLACED AND INTRA-OPERATIVE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. HOWEVER, INTRA-OPERATIVE DIAGNOSTICS FOR THE SECOND LEAD INDICATED INVALID IMPEDANCES. X-RAYS DID NOT REVEAL ANY ANOMALIES. POSTOPERATIVE DIAGNOSTICS INDICATED INVALID IMPEDANCES. THE PATIENT WAS TAKEN BACK INTO SURGERY AND THE SECOND LEAD WAS EXPLANTED. INTRA-OPERATIVE DIAGNOSTICS SHOWED IMPEDANCE READINGS WITHIN NORMAL LIMITS. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420486 LAMITRODE 44 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3254 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: