BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3575344 · Received January 14, 2014

    Report

    Report Number
    3007566237-2014-00180
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    January 9, 2001
    Report Date
    March 8, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT TYPE: LEAD, PRODUCT ID: 3888, SERIAL# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    HUBER, S., VAGLIENTI, R. M., HUBER, J. S. SPINAL CORD STIMULATION IN SEVERE, INOPERABLE PERIPHERAL VASCULAR DISEASE. NEUROMODULATION. 2000;3(3):131-143. SUMMARY: THE OBJECTIVE OF THE STUDY WAS TO ASSESS THE EFFECT OF SPINAL CORD STIMULATION IN PATIENTS WITH SEVERE, INOPERABLE PERIPHERAL VASCULAR DISEASE AND UNCONTROLLED PAIN. A CASE STUDY OF 20 PATIENTS WITH END-STAGE PERIPHERAL VASCULAR DISEASE EITHER FONTAINE CLASS 3 OR 4 LIMB ISCHEMIA. ALL 20 PATIENTS IMPLANTED WITH SCS DEVICE WITH FOLLOW-UP FROM ONE TO FIVE YEARS PERFORMED IN A MULTIDISCIPLINARY PAIN TREATMENT CENTER. IN THE 20 PATIENTS IMPLANTED, THERE WAS 75% LIMB SALVAGE, WITH FONTAINE CLASS PATIENTS, THERE WAS 86% AND WITH FONTAINE CLASS 4 PATIENTS, 69% LIMB SALVAGE OF THE TREATED LIMBS. REPORTED EVENTS: 1 PATIENT HAD A LEAD REPLACED DUE TO FRACTURE. 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
    35665 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention