BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2786440 · Received October 12, 2012

    Report

    Report Number
    3004209178-2012-09160
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 16, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V210850, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V234704, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE UNDESIRED CHANGES IN GAIT ON THE DATE OF REPORT. IT WAS UNKNOWN IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON OR OFF AS THE PATIENT WAS IN THE EMERGENCY ROOM (ER) AND THE PATIENT'S PROGRAMMER (PP) COULD NOT BE LOCATED. LIMITED TROUBLESHOOTING WAS POSSIBLE AS THERE WAS NO ACCESS TO A PP OR PHYSICIAN'S PROGRAMMER. THE REPORTER WAS REDIRECTED TO CALL THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP). THE REPORTER HAD A PAGE INTO THE ON-CALL NEUROLOGIST. THE PATIENT'S MANAGING HCP WAS UNKNOWN AT THE TIME OF REPORT AS THE PATIENT'S CARD INDICATED A FOLLOW-UP PHYSICIAN WHO HAD MOVED TO NEW YORK (NY). THE REPORTER WAS ALSO ADVISED TO CALL THE MANUFACTURER'S NATIONAL ANSWERING SERVICE TO PAGE THE LOCAL MANUFACTURER'S REPRESENTATIVE. DEVICE REGISTRY RECORDS FOR THE PATIENT INDICATED THAT TWO INSS WERE IMPLANTED AT THE TIME OF REPORT; THUS, IT WAS NOT CLEAR IF ONE OR BOTH INSS WERE INVOLVED IN THE EVENT. A REPORT HAS BEEN SUBMITTED FOR BOTH DEVICES.

    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 65 YR