BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2061937 · Received April 5, 2011

    Report

    Report Number
    3007566237-2011-02618
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A QUAD LEAD IMPLANTED FOR SACRAL NERVE STIMULATION BUT WAS REMOVED A WEEK LATER AS PATIENT HAD AN INFECTION AND OTHER COMPLICATIONS. BLOOD TESTS CAME BACK CLEAR AND IT WAS SUSPECTED THE PATIENT HAD A URINARY TRACT INFECTION. THERE WAS NO SIGN OF INFECTION AT THE DEVICE POCKET. THE LEAD HAD ALSO MOVED AS HER AREA OF PARESTHESIA CHANGED. THE HEALTHCARE PROVIDER (HCP) NOTICED THAT THE ANCHOR WAS NOT SECURE ON THE LEAD. THE HCP HAD USED THREE SUTURES TO SECURE THE ANCHOR TO THE LEAD, BUT IT HAD NOT GRIPPED THE LEAD APPROPRIATELY. ONCE THE LEAD WAS REMOVED HE SUTURED TIES AROUND THE LEAD AS HE WOULD NORMALLY DO 'IN-SITU', AND THE ANCHOR STILL MOVED UP AND DOWN THE LEAD. THE SYSTEM WAS REMOVED DUE AS A SECOND LEAD WAS NOT PLACED DURING THE TRIAL AND THE HCP OPTED TO WAIT TO RETRY DUE TO EDEMA OF THE NERVE ROOTS. THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 STIM ACCESSORY: MODEL 3550-39, LOT# 0204699874| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# 0204745842| EXPLANTED:| IMPLANTED: