BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 5000830 · Received August 13, 2015

    Report

    Report Number
    3004209178-2015-15950
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 20, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3389S-40, LOT# V210850, IMPLANTED: 2010-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3389S-40, LOT# V561214, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(4): THE CONSUMER REPORTED THAT THEY'VE HAD THREE DEEP BRAIN STIMULATOR (DBS) DEVICES AND THEY "ARE NOT WORKING. NO INTERVENTIONS, TROUBLESHOOTING, POTENTIAL CAUSES OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. INDICATIONS FOR USE: ESSENTIAL TREMOR MOVEMENT DISORDERS REFER TO MANUFACTURER REPORT # 3004209178-2015-15948.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533320 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR