BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2951395 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01524
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    January 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3387S-40 LOT# V014583, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V014846, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IN THE EMERGENCY ROOM FOR CHEST PAIN. THE PATIENT PROGRAMMER WAS USED TO TURN THE PATIENT'S THERAPY OFF FOR AN ECG (ELECTROCARDIOGRAPH). AFTER THE ECG WHEN THE THERAPY WAS TURNED BACK ON, "THEY GOT ECG INTERFERENCE BACK" BUT THE DEVICE LIGHT ON THE PATIENT PROGRAMMER DID NOT COME BACK ON. IT WAS UNCLEAR IF THE ECG INTERFERED WITH THE DEVICE, OR THE DEVICE INTERFERED WITH THE ECG. IT WAS REPORTED THAT THE PATIENT PROGRAMMER BATTERIES WERE REPLACED AND THE DEVICE LIGHT STILL DID NOT COME BACK ON. THE REPORTER STATED THAT NO BLINKING LIGHTS WERE SEEN PRIOR TO TURNING THE THERAPY OFF. THERE WERE MULTIPLE ATTEMPTS WITH THE SAME RESULT. IT WAS REPORTED THAT A HEALTHCARE PROVIDER WOULD TELL THE PATIENT TO FOLLOW UP WITH THEIR NEUROLOGIST. 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
    57568 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1