BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2783055 · Received October 11, 2012

    Report

    Report Number
    3004209178-2012-09100
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 26, 2012
    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 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387S-40, LOT# V012374, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V571557, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE CAUSE FOR THE EVENT WAS UNKNOWN. ABNORMAL IMPEDANCE MEASUREMENTS WERE FOUND ON AN ELECTRODE PAIR (0 AND 3 = 1406, <(><<)>15 AT 3 VOLTS). IT WAS STATED THAT THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN INSTEAD OF A MAGNETIC RESONANCE IMAGING (MRI) FOR AN UNRELATED BRAIN ISSUE. NO INJURY WAS REPORTED AND HOSPITALIZATION WAS NOT REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CHECKING THE IMPEDANCES PRIOR TO AN MAGNETIC RESONANCE IMAGING (MRI), LOW IMPEDANCES WERE FOUND ( LESS THAN 250 OHMS). THE LEFT SIDE IMPEDANCES WERE WITHIN NORMAL RANGE. THE RIGHT SIDE IMPEDANCE WAS WITHIN NORMAL RANGE EXCEPT FOR ELECTRODE PAIR 4 <(>&<)> 5 WITH 56 OHMS 229 MA. IT WAS NOTED THAT PATIENT DID NOT USE THIS ELECTRODE PAIR IN PROGRAMMING. WHEN THE REPRESENTATIVE CONDUCTED THE IMPEDANCE MEASUREMENTS AT BOTH 1.5 VOLT AND 3 VOLT, THE PATIENT HAD PAIN IN HIS TEETH. THIS HAPPENED ONLY DURING THE IMPEDANCE TESTS. THE PATIENT TYPICALLY RAN STIMULATION ON THE LEFT SIDE AT 2.0 VOLT AND 2.7 VOLT ON THE RIGHT SIDE. FOLLOW-UP INFORMATION REPORTED THAT THE PAIN DID RESOLVE. THE MRI WAS NOT PERFORMED AND THE PATIENT WAS RETURNED TO DOCTOR'S OFFICE ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1