BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-4 LEAD KIT, 60CM LENGTH

    MDR report key: 4628060 · Received March 24, 2015

    Report

    Report Number
    1627487-2015-06123
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 13, 2015
    Report Date
    June 12, 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
    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

    (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

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2015 AT WHICH TIME THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE STIMULATION COVERAGE WAS REPORTEDLY RESTORED POSTOPERATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT MET WITH AN SJM REPRESENTATIVE FOR A POSTOPERATIVE PROGRAMMING SESSION FOLLOWING A LEAD REVISION PROCEDURE (REFERENCE MFR REPORT # 1627487-2014-20520-01). SYSTEM DIAGNOSTICS REVEALED HIGH IMPEDANCE READINGS ON SEVERAL LEAD CONTACTS. X-RAYS TAKEN INDICATED THE PATIENT HAD AGAIN EXPERIENCED LEAD MIGRATION. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE. THE PATIENT HAS TWO MODEL 3246 LEADS FROM THE SAME LOT IMPLANTED AS PART OF HER SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195805 LAMITRODE S-4 LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3246 4754264

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other MODEL 3788, SCS IPG