BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2596320 · Received June 1, 2012

    Report

    Report Number
    3004209178-2012-03960
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Report Date
    June 12, 2012
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IMPLANTED: 2010 (B)(6), PRODUCT TYP EXTENSION, PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYP EXTENSION, PRODUCT ID 3387S-40, LOT# V163388, IMPLANTED: 2010 (B)(6), PRODUCT TYP LEAD, PRODUCT ID 3387S-40, LOT# V451316, IMPLANTED: 2010 (B)(6), PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS THAT IT WAS DIFFICULT TO CONTROL THE PATIENT¿S TREMOR AND SUPERFICIAL/MEDIAL PLACEMENT OF THE LEAD COMPONENT. THE LEAD PLACEMENT WAS CONFIRMED PER X-RAY/MRI/CT SCAN ON (B)(6) 2011. PATIENT SYMPTOMS OF LACK OF TREMOR CONTROL WERE REPORTED. REPROGRAMMING WAS ATTEMPTED ON (B)(6) 2011 WITH THE RESULTS NOTED AS RIGHT VENTRAL INTERMEDIATE NUCLEUS (VIM) HAD GOOD THRESHOLDS AND THAT THE LEFT VIM SHOWED IMPROVEMENT BUT IT WAS UNCLEAR IF THE BENEFIT WOULD BE SUSTAINED. A REVISION WAS RECOMMENDED BUT WAS DECLINED BY THE PATIENT. HOSPITALIZATION WAS NOT REQUIRED AND THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THAT, IN ADDITION TO THE DEVICE PROBLEMS ALREADY REPORTED, THE PATIENT ALSO EXPERIENCED VOICE PROBLEMS WHEN TURNING ON THE RIGHT SIDE DEVICE. IT WAS STATED WHEN THE DEVICE IS ON, HIS VOICE COULD NOT BE UNDERSTOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT SIDED DEVICE WAS NOT WORKING. THE LEAD PLACEMENT WAS NOT IDEAL, BUT HAVING A REVISION COULD MAKE HIS LEGS WORSE. THE PATIENT ONLY TURNS THAT DEVICE ON TO EAT AND WRITE. THE PATIENT WAS NOT GIVEN A PROGRAMMER, BUT HE USED THE MAGNET TO TURN THE DEVICE ON AND OFF, WHICH WAS DIFFICULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1