BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 5436800 · Received February 15, 2016

    Report

    Report Number
    3007566237-2016-00774
    Event Type
    Injury
    Date Received
    February 15, 2016
    Date of Event
    November 17, 2015
    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

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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 EVENTS. 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 STIMULATOR (SCS) FOR FAILED BACK SURGERY SYNDROME FOLLOWING A RIGHT LUMBAR MICRODISCECTOMY EXPERIENCED A RETURN OF SYMPTOMS TO PREOPERATIVE LEVELS FOUR WEEKS AFTER IMPLANTATION. INTERROGATION OF THE SYSTEM REVEALED HIGH IMPEDANCES SUGGESTIVE OF ELECTRODE FAILURE. AN X-RAY OF THE SYSTEM INDICATED ABNORMAL TWISTING OF THE WIRING BETWEEN THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE SPINAL ELECTRODE. UPON THIS EVIDENCE THE AUTHORS DIAGNOSED THIS PATIENT AS HAVING TWIDDLER¿S SYNDROME. THE PATIENT REPORTEDLY DENIED MANIPULATING THE INS, BUT THE SUBCUTANEOUS INS HAD UNDERGONE REPEATED ROTATION, TWISTING THE CONNECTING LEADS TO THE POINT OF FRACTURE. SURGICAL REVISION OF THE SYSTEM WAS PERFORMED. THE X-RAY FINDINGS WERE CONFIRMED INTRAOPERATIVELY: THE INS HAD ROTATED ON ITS AXIS MANY TIMES. A NEW INS WAS IMPLANTED IN HER RIGHT LUMBAR REGION ABOVE THE ILIAC CREST AND BELT LINE. POSTOPERATIVELY, THE PATIENT REPORTED RESTORATION OF GOOD PAIN RELIEF. THE AUTHORS NOTED THAT IT WAS NOT THEIR PRACTICE TO SUTURE THE INS INTO THE SUBCUTANEOUS POCKET. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN 8-ELECTRODE SURGICAL LEAD. NO ADDITIONAL DEVICE DETAILS WERE 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
    93232 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention