BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2814719 · Received November 1, 2012

    Report

    Report Number
    3004209178-2012-09803
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 4, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(4) 2006, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 64001, LOT# N288294, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387S-40, LOT# V012374, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS REPORTEDLY LYING IN BED WHEN HE FELT HE WAS "ELECTROCUTED ABOUT 3-4 TIMES AND THEY LAST ABOUT 3-4 SECONDS EACH TIME". IT WAS NOTED THAT THE PATIENT HAD TO "CRAWL" THE DAY PRIOR TO THIS REPORT BECAUSE HE "DIDN'T HAVE THE STRENGTH OR BALANCE" TO WALK. IT WAS STATED THAT THE DEVICE WAS "WORKING GREAT" AND DID NOT HAVE ANY ISSUES PRIOR TO THESE EVENTS. THE PATIENT REPORTEDLY DID NOT FEEL "THE CHANGING" WHEN SWITCHING BETWEEN GROUPS. IT WAS NOTED THAT THE PROGRAMMER WAS SYNCING WELL WITH THE IMPLANTABLE NEUROSTIMULATOR, THE BATTERY LEVELS WERE "GOOD", AND THE PATIENT WAS GETTING STIMULATION. A COUPLE WEEKS LATER, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE. REFER TO MEDICAL DEVICE REPORT # 3004209178-2012-09801.

    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 00052 YR