BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3092809 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07303
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 22, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0230913V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0230913V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS ON BIPOLAR PAIRS. IT WAS ALSO REPORTED THE ELECTRODE PAIR 1-3 HAD AN IMPEDANCE READING GREATER THAN 2,000 OHMS FOR THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) IN (B)(6), 2012. IT WAS NOTED THE RIGHT INS IMPEDANCE READINGS WERE GREATER THAN 2,000 OHMS FOR ALL BIPOLAR PAIRS. IT WAS ALSO STATED THE CURRENT MEASUREMENTS AT THE TIME OF REPORT AND THE PREVIOUS MEASUREMENTS WERE BETWEEN 9-12 MICROAMPS, WHICH IS POSSIBLY INDICATIVE OF AN OPEN CIRCUIT. IT WAS REPORTED IT HAD BECOME HARDER FOR THE PATIENT TO WRITE, WHICH HAD BEEN A PROBLEM 'MORE SO LATELY.' ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. REFERENCE REGULATORY REPORT #3004209178-2013-07302.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED, THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS ALSO REPORTED THERE WERE IMPEDANCES GREATER THAN 2000 OHMS ON ELECTRODE COMBINATIONS 1-3 AND 0-3 ON THE LEFT SIDE AND THE THERAPY IMPEDANCE ON THE RIGHT SIDE WAS GREATER THAN 2000 OHMS. IT WAS NOTED THERE WERE NO SIGNS OR SYMPTOMS RELATED TO THE EVENT AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION. IT WAS STATED THAT EVEN THOUGH THE PATIENT HAD ABNORMAL IMPEDANCES THEY STILL HAD GOOD TREMOR CONTROL WHILE USING THE SAME ELECTRODE CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194469 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1