BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3143105 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08558
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 14, 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

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3389-40, LOT# J0406024V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3389-40, LOT# J0406024V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BOTH OF THEIR IMPLANTABLE DEVICES REPLACED ON THE DAY OF REPORT PROPHYLACTICALLY AT THE REQUEST OF THEIR DOCTOR. IT WAS NOTED THAT THE BATTERY VOLTAGES WERE AT 2.6V. IT WAS NOTED THAT LOW IMPEDANCES WERE READ AT <(><<)>50 ON BIPOLAR PAIRS. IT WAS NOTED THAT SHORT CIRCUITS WERE ON THE LEFT SIDE. IT WAS FURTHER NOTED THAT THE PATIENT HAD TWO FALLS A MONTH PRIOR TO REPORT BUT WAS NOTED THAT THERE WEREN¿T ANY CHANGES IN THERAPY SINCE THE FALLS. DURING THE PROCEDURE, THE PATIENT HAD A SUPRAVENTRICULAR TACHYCARDIA (SVT) EPISODE AND THE REPLACEMENT WAS CANCELED. THE RESCHEDULED REPLACEMENT OCCURRED ON (B)(6)-2013 AND THE IMPEDANCES WILL GET CHECKED AT THE NEXT VISIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATED OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178-2013-08555 FOR REPORT ON PATIENT WITH IMPEDANCE ISSUE ON THEIR BILATERAL DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD BEEN SEEN BY THE HCP (HEALTHCARE PROFESSIONAL) ON (B)(6) 2013. THERAPY IMPEDANCE WAS WITHIN NORMAL RANGE. IT WAS STATED THAT THE PATIENT WAS RECEIVING BENEFIT FROM DBS (DEEP BRAIN STIMULATOR) AND HER THERAPY WAS NOT AFFECTED. IT WAS STATED THAT THE PATIENT HAD BEEN CLEARED BY A CARDIOLOGIST PRIOR TO HAVING DBS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244713 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention