BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2800237 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09409
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V616865, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V674524, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS UNABLE TO TURN THE DEVICE BACK ON EVEN THOUGH IT WORKED FINE TO TURN THERAPY OFF LAST NIGHT AT 10PM, WHICH SHE DOES EVERY NIGHT. THE DEVICE'S 9V BATTERY LIGHTS AND PASSES SELF-TEST WHEN REINSERTED. IT WAS ALSO REPORTED THAT THE PATIENT'S SUTURES BROKE IN BOTH POCKETS, SO THE DEVICES ROTATE A LITTLE BIT. THE PATIENT WAS GOING TO CONTACT THE MANUFACTURER REPRESENTATIVE TO CHECK THE DEVICES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLEASE REFER TO MANUFACTURER'S REPORT NO. 3004209178-2012-09408.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1