BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3231422 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00396
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    DEVICE 1 OF 3. REFERENCE MFR REPORT #S 1627487-2013-00397 AND 1627487-2013-00405. IT WAS REPORTED THE PT (B)(6) LOST STIMULATION FOR 10 DAYS. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN FOR FURTHER INTERROGATION. DURING THE PROCEDURE, IT WAS NOTED THE PT'S IPG WAS DEPLETED. AS SUCH, THE DEVICE WAS EXPLANTED AND REPLACED. THE PT'S EXTENSION WAS ALSO EXPLANTED. IMPEDANCE READINGS WERE REPORTEDLY NORMAL FOLLOWING THE PROCEDURE. ONLY THE EXPLANTED EXTENSION WAS RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323677 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other