BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2963616 · Received February 15, 2013

    Report

    Report Number
    3007566237-2013-00498
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 28, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ZIPES, D. P., SVORKDAL, N., BERMAN, D., BOORTZ-MARX, R., HENRY, T., LERMAN, A., ROSS, E., TURNER, M., IRWIN, C. SPINAL CORD STIMULATION THERAPY FOR PATIENTS WITH REFRACTORY ANGINAWHO ARE NOT CANDIDATES FOR REVASCULARIZATION. NEUROMODULATION. 2012;15(6):550-558. DOI: 10.1111/J.1525-1403.2012.00452.X. SUMMARY: THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF SPINAL CORD STIMULATION (SCS) FOR REFRACTORY ANGINA. THIS MULTICENTER, RANDOMIZED, SINGLE-BLIND, CONTROLLED TRIAL EVALUATED SCS IN TWO PATIENT GROUPS: HIGH STIMULATION (HS) (TREATMENT) AND LOW STIMULATION (LS) (CONTROL). THE HS GROUP CONTROLLED SCS WITH A PROGRAMMER FOR A MINIMUM OF TWO HOURS FOUR TIMES DAILY. THE LS GROUP RECEIVED SCS THERAPY ABOVE THE PARESTHESIA THRESHOLD FOR ONE MIN ONCE DAILY. THE PRIMARY EFFICACY ENDPOINT WAS NUMBER OF ANGINA ATTACKS RECORDED BY PATIENTS AT SIX MONTHS. THE PRIMARY SAFETY ENDPOINT WAS THE MAJOR ADVERSE CARDIAC EVENT (MACE) RATE AT SIX MONTHS. DUE TO SLOW ENROLLMENT, A FUTILITY ANALYSIS WAS PERFORMED, RESULTING IN EARLY TERMINATION OF THE STUDY. SIXTY-EIGHT PATIENTS WERE RANDOMIZED AFTER IMPLANTATION. MEAN CHANGE IN ANGINA ATTACKS PER DAY FROM BASELINE TO SIX MONTHS WAS -1.19+/-2.13 (HS) AND -1.29+/-1.66 (LS). THE DIFFERENCE FROM BASELINE WAS SIGNIFICANT WITHIN EACH GROUP (BOTH P < 0.001) BUT NOT BETWEEN GROUPS (P = 0.45). TOTAL EXERCISE TIME AND TIME TO ANGINA ONSET INCREASED SIGNIFICANTLY FROM BASELINE TO SIX MONTHS WITHIN EACH GROUP (BOTH P = 0.02 AND 0.002) BUT NOT BETWEEN GROUPS (P = 0.52 AND 0.51). MACE WAS SIMILAR BETWEEN GROUPS. ALTHOUGH THIS STUDY WAS TERMINATED EARLY, THE RESULTS OBTAINED AT SIX MONTHS SUGGEST THAT SCS (HS) IS NOT MORE EFFECTIVE THAN THE CONTROL (LS) IN PATIENTS WITH REFRACTORY ANGINA. REPORTED EVENTS: 8 INSTANCES OF NONFATAL MYOCARDIAL INFARCTION WERE REPORTED. THREE INSTANCES OF REVASULARIZATION WERE REPORTED. FIFTEEN INSTANCES OF MAJOR ADVERSE CARDIAC EVENTS WERE REPORTED. SIX PATIENTS EXPERIENCED SHOCKING OR DISCOMFORT, LIKELY DUE TO AN INCREASE IN STIMULATION. TWO PATIENTS EXPERIENCED AN INCREASE IN STIMULATION. FIVE PATIENTS EXPERIENCED INADEQUATE PAIN RELIEF. EIGHT INSTANCES OF LEAD MIGRATION/DISLODGMENT WERE REPORTED. FIVE PATIENTS EXPERIENCED INFECTION. SEVENTY-ONE INSTANCES OF UNSTABLE ANGINA WERE REPORTED. NINE PATIENTS EXPERIENCED CONGESTIVE HEART FAILURE. EIGHT PATIENTS EXPERIENCED ACUTE NON-Q-WAVE MYOCARDIAL INFARCTION. FOUR PATIENTS EXPERIENCED NEUROLOGIC DISORDER. 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
    66979 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention