BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1083103 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04315
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT'S HUSBAND REPORTED THAT HIS WIFE'S DEVICE TURNED OFF AUTOMATICALLY. THEY DIDN'T REALIZE IT WAS TURNED OFF FOR 3 DAYS. THE HUSBAND STATED THAT HE DIDN'T RECOLLECT THAT HIS WIFE HAD BEEN NEAR ANYTHING THAT COULD HAVE CAUSED ELECTROMAGNETIC INTERFERENCE. NO PT SYMPTOMS WERE REPORTED. HE WAS ENCOURAGED TO CONTACT THE PT'S HEALTH CARE PROFESSIONAL. 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 #3004209178-2008-04316.

    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 76 YR LEAD MODEL 3389 LOT#J0454304V| EXTENSION MODEL 7482 LOT#NHU075974V| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT#NHU058375V| EXPLANTED| STIMULATOR MODEL 7426| IMPLANTED| EXPLANTED| LEAD MODEL 3389 LOT#J0428089V