BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4232862 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21088
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE; IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# J0527200V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387-40, LOT# J0527200V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE IDENTICAL IMPEDANCES ON 3 OF CASE ELECTRODES. IT WAS NOTED WITH BIPOLAR IMPEDANCE 0 AND 3 - 50 OHMS, 1 AND 2 - 50 OHMS. PATIENT WAS PROGRAMMED ON PROGRAMMED ON C1 542OHMS. 60US, 185HZ. THE THERAPY STATUS OF THE PATIENT WAS UNKNOWN AND THEY DIDN¿T SAY THE PATIENT¿S THERAPY WAS AFFECTED BY THE IMPEDANCES. THEY NOTICED THE BATTERY VOLTAGE WAS AT 3.71 AT THE PREVIOUS SESSION AND AT THE TIME OF REPORT IT WAS AT 3.67. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712717 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR