BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1278107 · Received November 24, 2008

    Report

    Report Number
    3004209178-2008-07705
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD BEEN EXPERIENCING A GRADUAL LOSS OF THERAPEUTIC EFFECT (TREMOR CONTROL) ON THE LEFT SIDE AND A CHANGE IN GAIT. THERE WAS NO KNOWN EVENT RELATED TO THE ONSET OF THE SYMPTOMS. THE PT WAS SEEN IN THE CLINIC. IMPEDANCE READINGS WERE NORMAL ON THE LEFT SIDE. THE RIGHT SIDE GAVE READINGS OF >2000 OMHS (0/CASE = 2000; 1/CASE = >2000; 2/CASE = >2000; 3/CASE = >2000; 1/2 = 1686; 1/3 = >2000). THE PT WAS PROGRAMMED AT 2 VOLTS, 120 PULSE WIDTH, RATE 185 AND CASE 0. REPROGRAMMING WAS ATTEMPTED WITH ONE AND TWO ELECTRODES, BUT THE SYMPTOMS WORSENED. AN X-RAY WAS BEING CONSIDERED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD MODEL LEADMVD LOT# UNK| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU096102V| EXPLANTED:| LOT# NFW127805H| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7426| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL LEADMVD LOT# UNK| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU099193V| EXPLANTED: