BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2925691 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00842
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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: 3389S-40 LOT# V659421, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389S-40 LOT# V676860, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389S-40 LOT# V659421, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389S-40 LOT# V676860, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE RETURNED TO FACTORY SETTINGS AFTER IT WAS INTERROGATED ON (B)(6) 2012. THE REPORTER STATED THAT THE DEVICE WAS INTERROGATED WITH AN ACCESS REVIEW DEVICE AND WAS THEN INTERROGATED WITH A CLINICIAN PROGRAMMER. IT WAS NOTED THAT THE DEVICE WAS TURNED ON. DURING THE INTERROGATION WITH THE CLINICIAN PROGRAMMER, THERE WAS A MESSAGE OF "INVALID PARAMETER." THE INTERROGATION THEN SHOWED THAT THE DEVICE WAS RESET TO 0 VOLTS, A PULSE WIDTH OF 210, A RATE OF 30, AND WAS TURNED OFF. IT WAS REPORTED THAT THE DOCTOR PROGRAMMED THE DEVICE BACK TO THE PATIENT'S THERAPEUTIC SETTINGS WITH NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31387 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR