BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3010529 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01276
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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

    IT WAS REPORTED DURING AN IPG REVISION SURGERY ON (B)(6) 2013, THE PHYSICIAN ACCIDENTALLY CUT THE PT'S LEAD. THE LEAD WAS REPLACED WITH A NEW ONE. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PLACING THE NEW LEAD. THE PT ALSO EXPERIENCED A CSF LEAK. THE SURGICAL PROCEDURE WAS EXTENDED 3-4 HOURS. THE PT HAD A SEVERE HEADACHE AND WAS TREATED WITH PAIN MEDICATION. FOLLOW UP INFORMATION ON (B)(6) 2013 IDENTIFIED THE PT IS STILL HAVING SEVERE HEADACHES WHEN HE SITS OR STANDS. ON (B)(6) 2013, THE PT WENT TO THE HOSPITAL DUE TO THE SEVERE HEADACHES. A CT SCAN SHOWED A PNEUMOCEPHALUS, AND A SMALL CSF LEAK, THE PHYSICIAN WILL MONITOR THE PT AND TREAT WITH MEDICATION FOR THE HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108280 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3767558

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS IPG: MODEL 3788