BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4788704 · Received May 21, 2015

    Report

    Report Number
    3004209178-2015-09540
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: 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: 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING PROBLEMS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS IMPLANTED IN THE RIGHT SIDE OF THEIR CHEST. THE INS KEPT TURNING OFF. THE PATIENT MET WITH THEIR HEALTHCARE PROFESSIONAL (HCP) AND BOTH INSS LOOKED FINE. WHEN THE INS DID TURN ITSELF OFF, THEY WERE ABLE TO MANUALLY TURN THE INS BACK ON. THE PATIENT WAS TO CONTINUE TO MONITOR AND TRACK WHEN THE INS TURNED OFF. NO INTERVENTIONS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333119 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR