BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1083094 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04338
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A GRADUAL RETURN OF SYMPTOMS. THE PATIENT DIDN'T RELATE THE RETURN OF SYMPTOMS TO THE STIMULATION THERAPY. THE DEVICE HAD NOT BEEN CHECKED IN APPROXIMATELY EIGHT MONTHS. THE PATIENT REPORTED THE DEVICE TURNS OFF, BUT DIDN'T KNOW WHEN IT OCCURS. THE PATIENT ALSO HAD A SLEEP APNEA SYSTEM; HE WAS GOING TO CHECK THE DEVICE BEFORE GOING TO BED AND KEEP A DIARY OF WHEN THE DEVICE TURNS OFF TO CHECK IF THE SLEEP APNEA MACHINE HAS ANY EFFECT ON THE GENERATOR. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 3004209178200804336.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXTENSION MODEL 7472 LOT# NHU107912V| EXTENSION MODEL 7482 LOT# NHU109262V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# V000198| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# V0000198