BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1083105 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04328
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 25, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION THROUGHOUT HER ENTIRE BODY THAT CAME ON SUDDENLY. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PT HAD REPORTED THAT THE EVENT TO HER HEALTH CARE PROFESSIONAL (HCP), AND THE PLAN WAS TO TURN DOWN THE SETTINGS AT HER NEXT APPOINTMENT. THE PT WAS ENCOURAGED TO CONTINUE TO ADDRESS THE ISSUE WITH HER HCP. THE PT WAS AT HOME AND HER CONDITION WAS REPORTED TO BE "FAIR". ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE MANUFACTURER'S REPORT #3004209178-2008-04329.

    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 63 YR Required Intervention LEAD MODEL 3387 LOT#V042088| IMPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| STIMULATOR MODEL 7426| EXPLANTED| EXTENSION MODEL 7482 LOT#NHU156516V| IMPLANTED| EXTENSION MODEL 7482 LOT#NHU156533V| IMPLANTED| LEAD MODEL 3387 LOT#V022287| IMPLANTED