BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5436861 · Received February 15, 2016

    Report

    Report Number
    3007566237-2016-00776
    Event Type
    Injury
    Date Received
    February 15, 2016
    Report Date
    January 21, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT(S) WITH PREVIOUSLY REPORTED EVENT(S). CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT AND EVENT INFORMATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    AL-MAHFOUDH, R., CHAN, Y., CHONG, H.P., FARAH, J.O. TWIDDLER'S SYNDROME IN SPINAL CORD STIMULATION. ACTA NEUROCHIRURGICA. 2016;158(1):147-154. DOI: 10.1007/S00701-015-2627-X. SUMMARY: THE AIMS ARE TO PRESENT A CASE SERIES OF TWIDDLER¿S SYNDROME IN SPINAL CORD STIMULATORS WITH ANALYSIS OF THE POSSIBLE MECHANISM OF THIS SYNDROME AND DISCUSS HOW THIS PHENOMENON CAN BE PREVENTED. REPORTED EVENTS: CASE (B)(4): A (B)(6) WOMAN WITH A SPINAL CORD STIMULATION (SCS) SYSTEM FOR FAILED BACK SURGERY SYNDROME IMPLANTED SINCE 2008 HAD GOOD CONTROL OF HER BACK PAIN INITIALLY, BUT DURING FOLLOW-UP HER PAIN CONTROL DETERIORATED. IN LATE 2009, SHE COMPLAINED OF HER IMPLANTABLE NEUROSTIMULATOR (INS) BEING MOBILE AND CATCHING ON HER CLOTHES AND IT WAS RE-SITED AT THAT POINT. IN 2013, SHE PRESENTED WITH SCS FAILURE. X-RAYS SHOWED SIGNS OF TWIDDLER¿S SYNDROME. THE PATIENT REPORTEDLY DENIED MANIPULATING THE INS. ON REVISION OF HER SCS, THE EXTENSION WIRES WERE BADLY TWISTED AND DAMAGED. SHE HAD A REPLACEMENT EXTENSION SET TUNNELED AND CONNECTED TO THE MAIN ELECTRODES, WITH THE INS REPOSITIONED TO THE LUMBAR REGION. THE AUTHORS NOTED THAT IT WAS NOT THEIR PRACTICE TO SUTURE THE INS INTO THE SUBCUTANEOUS POCKET. THIS PATIENT WAS IMPLANTED WITH A 39565 SURGICAL LEAD AT THE LEVEL OF T10-T12. NO OTHER DEVICE INFORMATION WAS PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93183 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention