BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3173685 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10462
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # J0417569V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # J0406558V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD ISSUE DISCOVERED IN 2006-2007. IT WAS THOUGHT THAT THERE WAS A LEFT LEAD FRACTURE BUT X-RAYS WERE NEGATIVE FOR LEAD FRACTURE. IT WAS LATER REPORTED THAT AN ADDITIONAL X-RAY WAS DONE THAT VALIDATED A BROKEN LEAD FROM 2006. NO EXPLANT WAS SCHEDULED. THE PATIENT DECIDED TO LEAVE THE INS OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SYSTEM IN QUESTION WAS ON THE PATIENT¿S LEFT SIDE. HIGH IMPEDANCES WERE MEASURED ON THE LEFT SIDE. NO FRACTURES WERE SEEN ON ANY FILMS. THE MANUFACTURING REPRESENTATIVE ATTEMPTED TO PROGRAM AROUND THE AFFECTED ELECTRODES, BUT THE PATIENT DID NOT RECEIVING ANY BENEFIT. THE PATIENT HAD KEPT THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND HAD DECIDED TO KEEP IT OFF UNTIL THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273075 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR