BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1023480 · Received April 2, 2008

    Report

    Report Number
    3004209178-2008-01739
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    January 1, 2007
    Report Date
    March 3, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED A RETURN OF TREMOR. DURING THE PAST 10 MONTHS THE PT'S DEVICE WAS REPROGRAMMED FOUR TIMES. PER THE PT, THE HEALTH CARE PROVIDER (HCP) STATED THERE IS A LOOSE CONNECTOR. THE HCP REPROGRAMMED THE DEVICE AND DOUBLED THE PT'S MEDICATIONS IN 2008, RESULTING IN TREMOR RELIEF. ADD'L INFO HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO FDA IF ADD'L INFO IS RECEIVED.

    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 IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT # N24966A| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT # XR0092679N