BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3200969 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11159
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    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
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748295, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V037067, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL BUT SEEMED TO BE OK AT FIRST. IT WAS NOTED LATER ON PATIENT WAS CONFUSED, COULD NOT TALK, HAD TROUBLE EATING AND DID NOT SEEM TO RESPOND TO INSTRUCTIONS. THE PATIENT HAD X-RAY¿S AND A CAT SCAN WAS DONE AND THERE WAS NO SIGN OF A STROKE. IT WAS NOTED THAT THE CALLER WANTED THE DEVICE CHECKED. THE PATIENT WAS IN THE HOSPITAL. IT WAS CONFIRMED BY THE HEALTH CARE PROVIDER THAT WHEN THE PATIENT FELL HE DID NOT LAND ON THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS NOT HAVING ANY TREMOR ISSUE. THE FALL HAD HAPPENED TWO DAYS PRIOR TO THE REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL. THE PATIENT WAS IN THE HOSPITAL FOR 3 DAYS AFTER THE FALL AND WAS THEN TRANSFERRED TO A REHAB FACILITY. THE PATIENT HAD NOT IMPROVED BUT WAS GETTING WORSE. THE PATIENT SEEMED TO BE IN ANOTHER WORLD, WAS FIXATED ON FIXING HIS WHEELCHAIR. IT WAS NOTED THE PATIENT LOOKED LIKE HE HAD A STROKE. IT WAS NOTED A COMPRESSED BONE IN THE LUMBAR SPINE WAS FOUND. CALLER INQUIRED ABOUT POSSIBLE IMPLANTED LEAD MOVEMENT. ADDITIONAL INFORMATION REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303109 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R