BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 5354646 · Received January 8, 2016

    Report

    Report Number
    3007566237-2016-00141
    Event Type
    Injury
    Date Received
    January 8, 2016
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) INDICATED THE PATIENT HAD RESIDUAL NEUROPATHIC LEG PAIN BUT THAT HAD NEVER BEEN CONFIRMED BY EMG OR ANY OTHER TESTING. THE HF10 THERAPY WAS ONLY SUCCESSFUL FOR BACK PAIN AND PELVIC PAIN. IT DID NOT SIGNIFICANTLY IMPROVE THE LEG PAIN AS MENTIONED IN THE ABSTRACT. THE HCP NOTED IT WAS DIFFICULT TO EVALUATE HOW THE LEG PAIN WAS OBJECTIVE. DETAILS ABOUT THE DURA CLOSURE AND THERAPY WERE NOT PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    BILLET, B., HANSSENS, K., CEUPPENS, J., VANDENBOSSCHE, C. SUCCESSFUL TREATMENT OF CHRONIC LOWER BACK PAIN AND POST-SURGICAL PELVIC PAIN WITH HF10: CASE REPORT (10658). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 343. SUMMARY: THE USE OF HIGH-FREQUENCY, PARESTHESIA-FREE SPINAL CORD STIMULATION (SCS) AT 10 KHZ (HF10 THERAPY) FOR CHRONIC INTRACTABLE LOW BACK PAIN HAS BEEN GAINING ACCEPTANCE IN THE PHYSICIAN COMMUNITY GIVEN THE LONG-TERM LEVEL 1 EVIDENCE IN THE CLINICAL LITERATURE. IN THIS CASE REPORT, WE PRESENT A PATIENT SUCCESSFULLY TREATED FOR HER CHRONIC LOWER BACK PAIN AND POST-SURGICAL PELVIC PAIN WITH HF10 THERAPY. REPORTED EVENTS: PATIENT WAS A (B)(6) WOMAN WHO PRESENTED AT THE CLINIC WITH LOWER BACK PAIN FROM FAILED BACK SURGERY SYNDROME (FBSS) AND POST-SURGICAL PELVIC PAIN (BURNING SENSATION IN VAGINAL AREA). BACK PAIN WAS A RESULT OF A LUMBAR FUSION (L5-S1) FOR HERNIATION. PELVIC PAIN WAS A RESULT OF TWO LAPAROTOMIES AND LOCAL RADIOTHERAPY TO REMOVE CERVICAL CARCINOMA. A COMPLICATED INTRATHECAL MORPHINE TRIAL RESULTED IN INSUFFICIENT PAIN RELIEF, NEW ONSET OF REFRACTORY UNILATERAL NEUROPATHIC LEG PAIN, POST-PROCEDURE HEADACHE AND A SURGICAL CLOSURE OF THE DURA. THE EVENT DATE, PATIENT IDENTIFICATION, AND PRODUCT INFORMATION WERE NOT REPORTED. IN ADDITION, NO DIAGNOSTICS PERFORMED FOR THE ADVERSE EVENTS WERE REPORTED. FURTHER FOLLOW-UP WAS BEING REQUESTED TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12642 INTRATHECAL CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention