BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3305302 · Received August 23, 2013

    Report

    Report Number
    3004209178-2013-15063
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Report Date
    July 29, 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 Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# V011992, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# V011992, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FALLING MORE OFTEN. IT WAS STATED THAT THE WEEK PRIOR TO THE REPORT, THE PATIENT FELL MORE. THE STIMULATOR ON THE LEFT SIDE WAS FOUND TO BE OFF WHEN IT WAS CHECKED ON 2013 (B)(6). THE REPORTER THOUGHT THE STIMULATOR MIGHT HAVE BEEN OFF ALL LAST WEEK AND MAY HAVE BEEN REASON WHY PATIENT WAS FALLING. THE STIMULATOR WAS TURNED BACK ON. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415012 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR