BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1001685 · Received February 15, 2008

    Report

    Report Number
    3004209178-2008-00720
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED DIFFICULTY WALKING AFTER GOING THROUGH THE AIRPORT WHILE TRAVELING. THE PT DID NOT HAVE THE HAND-HELD PROGRAMMER WITH HIM. THE PT DID NOT KNOW IF THE DEVICE WAS ON OR OFF. THE MFR REVIEWED THE BASIC FUNCTIONALITY OF USING A MAGNET TO TURN THE DEVICE ON OR OFF. THE PT WAS INSTRUCTED TO CONTACT THEIR HCP. ADDITIONAL INFO HAS BEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO THE FDA IF ADDITIONAL INFO IS RECEIVED. REFER TO MEDWATCH REPORT # 3004209178200800721.

    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:| LEAD MODEL 3387S LOT# V049666 IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482A LOT# NHU158611V IMPLANTED: