BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1150402 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05453
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 5, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION DOWN HER ARM WHEN SHE REACHED FOR SOMETHING. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. THE PATIENT HAD A FEW FALLS 'QUITE SOME TIME' BEFORE THE SHOCKING SYMPTOMS APPEARED. THE PATIENT STATUS WAS REPORTED AS 'FAIR' AT THE TIME OF THE COMPLAINT. THE PATIENT WAS SEEN TWICE BY HER HCP SINCE THE INITIAL COMPLAINT; DETAILS OF THE VISITS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 3004209178-2008-05454.

    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 EXTENSION MODEL 7482 LOT# NHU125344V| IMPLANTED| LEAD MODEL 3387 LOT# V006127| LEAD MODEL LEADMVD LOT# UNK| EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| LOT#: NFW134641H| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXTENSION MODEL 7482 LOT# NHU127200V| IMPLANTED