BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2923873 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00789
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 24, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA04FBP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A LEAD REVISION THE LEAD WAS RE-CONNECTED TO THE EXISTING EXTENSION AND ELECTRODES 1 AND 2 WERE LESS THAN FIFTY OHMS. FOLLOW UP REPORTED THE REPRESENTATIVE WAS UNSURE IF IMPEDANCES RESOLVED. IT WAS NOTED THE PATIENT HAD NOT YET BE PROGRAMMED. THE IMPEDANCE ISSUE WAS DUE TO AN UNKNOWN CAUSE. NO INTERVENTIONS WERE PLANNED OR HAD BEEN TAKEN. THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31133 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1