BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2480418 · Received March 6, 2012

    Report

    Report Number
    3007566237-2012-00476
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    July 19, 2006
    Report Date
    February 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED: UNK. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION. 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 MORE THAN ONE EVENT OCCURRED IN ONE PATIENT. (B)(4).

    Description of Event or Problem · 1

    ANDERSEN, C., ENGGAARD, T. P., SCHERER, C. SPINAL CORD STIMULATION HAS PROVEN BENEFIT ON PAIN AND QUALITY OF LIFE IN PATIENTS WITH ANGINA PECTORIS WHEN LESS INVASIVE THERAPIES HAVE FAILED. NEUROMODULATION 2006; 9(4): 314-319. SUMMARY: SINCE 1988, SPINAL CORD STIMULATION (SCS) HAS BEEN USED AT (B)(6) FOR PATIENTS WITH REFRACTORY ANGINA PECTORIS. THE AIM OF OUR PROSPECTIVE STUDY WAS TO EVALUATE THE LONG-TERM EFFECTS OF SCS ON PAIN, ACTIVITIES OF DAILY LIVING (ADLS), QUALITY OF LIFE (QOL), SLEEP HYGIENE, AND PHYSICAL FUNCTIONING FOR PATIENTS WITH ANGINA PECTORIS. BEFORE AND AFTER PLACEMENT OF SCS FOR PATIENTS WITH INTRACTABLE ANGINA PECTORIS, WE PERFORMED STRUCTURED TELEPHONE INTERVIEWS QUESTIONING FOR PAIN RELIEF, ADLS ((B)(6) HEALTH PROFILE), PHYSICAL FUNCTIONING ((B)(6) ANGINA QUESTIONNAIRE) AND SLEEP HYGIENE. OUT OF 150 PATIENTS WITH SCS OVER 15 YEARS, 41 PATIENTS HAD DIED, 46 PATIENTS HAD THEIR DEVICES EXPLANTED, AND FOUR PATIENTS DID NOT PARTICIPATE OR COULD NOT BE REACHED. THREE PATIENTS HAD LESS THAN 6 MONTHS OF FOLLOW-UP AND WERE THEREFORE NOT INCLUDED IN OUR ANALYSIS. THE BENEFICIAL EFFECTS OF SCS TREATMENT FOR INTRACTABLE ANGINA PECTORIS WERE REDUCTION IN PAIN AND IMPROVEMENT IN QOL. SLEEP PATTERN AND PHYSICAL FUNCTIONING WERE NOT IMPROVED TO THE SAME EXTENT AS REDUCTION IN PAIN OR IMPROVEMENT IN QOL. ALMOST ALL OF OUR SCS-TREATED PATIENTS DID RECOMMEND SCS FOR INTRACTABLE ANGINA PECTORIS. ABOUT 30% OF PATIENTS DISCONTINUED TREATMENT, THE MOST COMMON CAUSE BEING ELECTRODE DISPLACEMENT AND MALFUNCTION OF THE SYSTEM. OTHER REASONS FOR DISCONTINUED THERAPY WERE THE EVOLVEMENT OF INVASIVE TREATMENT OPTIONS SUCH AS CORONARY ARTERY BYPASS GRAFT AND PTCA AND USE OF SUCH OPTIONS IN SOME PATIENTS DURING OUR PROLONGED OBSERVATION PERIOD. THIS SURVEY SHOWS THAT SCS LEADS TO A 70-80% IMPROVEMENT IN PAIN, WHICH, IN TURN, LEADS TO IMPROVEMENT IN QOL, WHEREAS, PHYSICAL CONDITION AND SLEEP PATTERN DID NOT IMPROVE TO THE SAME EXTENT. REPORTED EVENTS: THREE PATIENTS HAD THEIR SCS SYSTEM REMOVED DUE TO INFECTION. TEN PATIENTS HAD THEIR SCS SYSTEM EXPLANTED DUE TO DISPLACEMENT OF THE ELECTRODE, RESULTING ON LACK OF PAIN RELIEF. REPORTED EVENT: FIVE PATIENTS HAD THEIR SCS SYSTEM REMOVED DUE TO DEVELOPMENT OF UNSPECIFIED NEUROLOGIC SYMPTOMS. REPORTED EVENT: FIVE PATIENTS HAD THEIR SCS SYSTEM REMOVED DUE TO BACK/HEAD DISCOMFORT. 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
    1 NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention LEAD MODEL UNK SERIAL/LOT# UNK IMPLANTED: UNK