BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3519774 · Received December 13, 2013

    Report

    Report Number
    3007566237-2013-04032
    Event Type
    Injury
    Date Received
    December 13, 2013
    Report Date
    November 20, 2013
    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
    HEALTH PROFESSIONAL

    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. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS BELIEVED THAT NONE OF THE BATTERIES MENTIONED IN THE ARTICLE WERE MEDTRONIC DEVICES. THE REPORTER STATED THAT IT WOULD BE LOOKED INTO FURTHER, BUT THE REPORTER WAS NOT HOPEFUL ANY FURTHER INFORMATION WOULD BE FOUND.

    Description of Event or Problem · 1

    MCAULEY, J., AYDIN, Y., GREEN C. R., VAN GRONINGEN, R. PATIENT¿S EXPERIENCES WITH SPINAL CORD STIMULATION FOR LUMBAR SPONDYLOTIC PAIN: COMFORT AT THE IMPLANTABLE PROGRAMMABLE GENERATOR SITE. J NEUROL NEUROSURG PSYCHIATRY. 2013. 84:E2. DOI: 10.1136/JNNP-2013-306573.121. SUMMARY: SPINAL CORD STIMULATION (SCS) IS AN EFFECTIVE TREATMENT FOR CHRONIC LUMBAR AND RADICULAR PAIN RESULTING FROM LUMBAR SPONDYLOSIS. HOWEVER, A PROPORTION OF PATIENTS EXPERIENCE DISCOMFORT AND COMPLICATIONS RELATED TO THE SUBCUTANEOUS SITE OF THE IMPLANTABLE PROGRAMMABLE GENERATOR (IPG) USED TO GENERATE THE STIMULATION FOR THE SPINAL CORD ELECTRODES. A QUESTIONNAIRE WAS PRODUCED TO EXPLORE PATIENTS¿ EXPERIENCES WITH SUCH ISSUES. REPORTED EVENT: 7 REVISIONS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE HAD TO BE PERFORMED IN 6 SPINAL CORD STIMULATION (SCS) PATIENTS IN ORDER TO ACHIEVE SATISFACTION. 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
    652486 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention