BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4636676 · Received March 26, 2015

    Report

    Report Number
    3004209178-2015-05475
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    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 Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V240350, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V240350, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL WHEN THEY GOT OUT OF THE CARE AND THEY HIT THEIR HEAD ON THE RIGHT SIDE. THE PATIENT HAD ABRASION ABOVE THEIR RIGHT EYE. PRIOR TO THE FALL, THE PATIENT WAS ABLE TO CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT THEY COULD NOT CONNECT AFTER. AT THE TIME OF THIS REPORT, THE PATIENT WAS ON THEIR WAY TO THE HOSPITAL. 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
    203747 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR