BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3481512 · Received November 21, 2013

    Report

    Report Number
    3004209178-2013-21196
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V210498, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V668795, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿LEFT BRAIN¿ HAD IMPEDANCE VALUES GREATER THAN 2000 ON ELECTRODE PAIRS 0 AND 2 AS WELL AS 0 AND 3. IT WAS NOTED THAT THE ¿RIGHT BRAIN¿ HAD IMPEDANCE VALUES GREATER THAN 2000 ON ELECTRODE PAIRS 0 AND 2 AS WELL AS 0 AND 3. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THIS EVENT AND THAT THE PATIENT OUTCOME WAS NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607302 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR