BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5436514 · Received February 15, 2016

    Report

    Report Number
    3007566237-2016-00770
    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 WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. 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 FAILED BACK SURGERY SYNDROME FOLLOWING A LUMBAR MICRODISCECTOMY HAD A SPINAL CORD STIMULATOR (SCS) INSERTED IN (B)(6) 2009 AND THE PATIENT EXPERIENCED GOOD RELIEF OF LOWER LIMB PAIN WITH STIMULATION. IN (B)(6) 2011, SHE UNDERWENT REPROGRAMMING WITH FAILURE TO ACHIEVE SATISFACTORY STIMULATION. HER IMAGING REVEALED TWISTING OF THE CONNECTING WIRES ADJACENT TO THE IMPLANTABLE NEUROSTIMULATOR (INS). UPON THIS EVIDENCE THE AUTHORS DIAGNOSED THIS PATIENT AS HAVING TWIDDLER¿S SYNDROME. THE PATIENT REPORTEDLY DENIED MANIPULATING THE INS. AS IT WAS STILL PARTIALLY FUNCTIONING, SHE CHOSE TO DEFER REVISION SURGERY. EVENTUALLY THE DEVICE FAILED COMPLETELY. IN (B)(6) 2012, HER INS WAS REPOSITIONED WITH NEW CONNECTOR LEADS. THE CONNECTOR WIRES WERE FOUND KNOTTED AND TWISTED INTRAOPERATIVELY. THE NEW WIRES WERE TUNNELED TO THE RIGHT LUMBAR REGION ABOVE THE BELT LINE. NO FURTHER PROBLEMS HAVE BEEN REPORTED ON FOLLOW-UP. THE AUTHORS NOTED THAT IT WAS NOT THEIR PRACTICE TO SUTURE THE INS INTO THE SUBCUTANEOUS POCKET. THE AUTHORS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A 37565 LEAD, BUT PROVIDED NO SPECIFIC DEVICE INFORMATION REGARDING THE EXTENSIONS OR INS. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93219 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention