BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3936117 · Received July 15, 2014

    Report

    Report Number
    3007566237-2014-01968
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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 PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD. LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    GAZELKA, H. M., FREEMAN, E. D., HOOTEN, W. M., ELDRIGE, J. S., HOELZER, B. C., MAUCK, W. D., MOESCHLER, S. M., PINGREE, M. J., RHO, R. H., LAMER, T. J. INCIDENCE OF CLINICALLY SIGNIFICANT PERCUTANEOUS SPINAL CORD STIMULATOR LEAD MIGRATION. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2014. DOI: 10.1111/NER.12184. SUMMARY: TO EXAMINE THE INCIDENCE OF PERCUTANEOUS SPINAL CORD STIMULATOR LEAD MIGRATION, GIVEN CURRENT HARDWARE AND SURGICAL TECHNIQUE. WE RETROSPECTIVELY REVIEWED RECORDS OF PATIENTS WHO UNDERWENT SPINAL CORD STIMULATOR IMPLANTATION WITH PERCUTANEOUS LEADS AT OUR INSTITUTION FROM 2008 THROUGH 2011.WE DETERMINED THE NUMBER OF PATIENTS WHO REQUIRED SURGICAL REVISION FOR CLINICALLY SIGNIFICANT LEAD MIGRATION. CLINICALLY SIGNIFICANT LEAD MIGRATION REQUIRING SURGICAL REVISION OCCURRED IN THREE OF 143 PATIENTS (2.1%) WITH PRIMARY SCS SYSTEM IMPLANTS UTILIZING PERCUTANEOUS-TYPE LEADS. THE RATE OF LEAD MIGRATION OBSERVED IN OUR PRACTICE WAS CONSIDERABLY LOWER THAN PREVIOUSLY PUBLISHED ESTIMATES OF CLINICALLY SIGNIFICANT LEAD MIGRATION OR REVISION FOR LEAD MIGRATION (13%¿22%). HOWEVER, OUR STUDY DID NOT DETERMINE THE REASON FOR THE DECREASED RATE, WHICH MAY BE INFLUENCED BY CURRENT HARDWARE AND IMPLANT TECHNIQUES. REPORTED EVENT: ONE PATIENT EXPERIENCED SIGNIFICANT LEAD MIGRATION IN THE CAUDAL DIRECTION WHICH REQUIRED A SURGICAL REVISION. IT WAS NOTED THAT THE PATIENT HAD LOST PARESTHESIA CAPTURE AS A RESULT AND IT COULD NOT BE RESTORED BY REPROGRAMMING. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    413747 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention