BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URGENT PC NEUROMODULATION SYSTEM

    MDR report key: 2999879 · Received March 8, 2013

    Report

    Report Number
    3002647932-2013-00001
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    UROPLASTY INC.
    Product Code
    NAM
    PMA / PMN Number
    K101847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED WAS THE COMBINATION OF THE REUSABLE URGENT PC STIMULATOR (UPC 200-A) AND SINGLE-USE URGENT PC LEAD SET (UPC 250-12) (TOGETHER, THE URGENT PC NEUROMODULATION SYSTEM). THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A PT WITH A HISTORY OF ANGINA EXPERIENCED CHEST PRESSURE IMMEDIATELY FOLLOWING HER URGENT PC TREATMENT. THE PHYSICIAN REFERRED HER TO THE ER, WHERE SHE WAS DIAGNOSED WITH MYOCARDIAL INFARCTION WITH COMPLETE OCCLUSION OF HER MAIN CORONARY ARTERY. SHE WAS HOSPITALIZED AND TREATED. ALTHOUGH NOT RESPONSIBLE FOR HER CORONARY ARTERY DISEASE, HER CARDIOLOGIST THOUGHT THE NEUROSTIMULATION PROCEDURE MAY HAVE HAD A PART IN HER INITIAL SYMPTOMS THAT SENT HER TO THE ER. SHE HAD UNDERGONE 6 TREATMENTS WITH URGENT PC PRIOR TO THIS INCIDENT WITHOUT ANY SYMPTOMS OR PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99470 URGENT PC NEUROMODULATION SYSTEM NAM UROPLASTY INC. UPC 200-A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R