BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2032464 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02290
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    August 1, 2007
    Report Date
    February 24, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PT INFO PROVIDED IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: FUMERO A, RAPATI D, DISO S, LAPENNA E, ALFIERI O. SPINAL CORD STIMULATION FOR REFRACTORY CHRONIC ANGINA PECTORIS: INFLUENCE ON QUALITY OF LIFE. EXPERT REV PHARMACOECON OUTCOMES RES, AUG 2007;7(4):343-349. SUMMARY: THE AUTHOR'S AIM WAS TO ASSESS THE BENEFITS, IN TERMS OF QUALITY OF LIFE, OF SPINAL CORD STIMULATION IN NO-OPTION PTS AFFECTED BY REFRACTORY ANGINA PECTORIS. BETWEEN (B)(6) 1998 AND (B)(6) 2007, 77 PTS WITH REFRACTORY ANGINA WERE TREATED WITH A TEMPORARY EXTERNAL DEVICE FOR A 4-WEEK TRIAL PERIOD. SEVENTY PTS HAD CLINICAL BENEFIT AND WERE IMPLANTED WITH A PERMANENT PULSE GENERATOR. THE MEAN PT AGE WAS (B)(6); THERE WERE 52 MALES AND 18 FEMALES. NO LIFE-THREATENING COMPLICATIONS RELATED TO TEMPORARY AND PERMANENT SCS IMPLANTATION WERE OBSERVED. THERE WERE NO INTRA-SURGICAL COMPLICATIONS RELATED TO SCS-IMPLANTATION. REPORTABLE EVENTS: THE AUTHORS REPORTED FOUR (N=4) ELECTRODE DISLODGEMENTS; REPOSITIONING WAS PERFORMED FOR EACH. THE AUTHORS REPORTED THREE (N=3) PTS EXPERIENCED A SKIN POCKET INFECTION. THE AUTHORS REPORTED TWO (N=2) PTS EXPERIENCED AN EXTENSION WIRE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC NEUROMODULATION 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LEAD: MODEL 3487, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487, LOT# UNK| EXPLANTED:| LEAD: MODEL 3487, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED: