BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2980242 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-15246
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 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
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15245. IT WAS REPORTED THE PATIENT LOST STIMULATION AFTER HE HAD A SEIZURE WHILE SLEEPING AND FELL OF OUT BED. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMING EFFORTS WERE UNSUCCESSFUL. X-RAYS INDICATED THE LEAD WAS DISCONNECTED FROM THE EXTENSION. THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S LEAD AND EXTENSION. THE EXPLANTED EXTENSION HAD WIRES COMING OUT OF IT AND THE LAST CONTACT ON THE DISTAL END OF THE LEAD WAS MISSING. WHEN TESTED INTRA-OPERATIVELY, THE LEAD WAS FOUND TO HAVE INVALID CONTACTS. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE. THE PATIENT INDICATES EFFECTIVE STIMULATION IS BEING PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78142 SINGLE EXTENSION SCS LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 3796698

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1192