BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3200263 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11145
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# V026239, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V036268, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS HAVING LOSS OF THERAPEUTIC EFFECT AND PATIENT HAS STARTED SHAKING ON THE RIGHT SIDE RECENTLY. IT WAS INDICATED THAT PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED ON THE RIGHT SIDE AND PATIENT WAS GETTING READING THAT THE INS WAS ON, BUT WAS NOT GETTING ANY RESPONSE FROM THE LEFT SIDE INS. IT WAS REPORTED THAT PATIENT¿S HEALTHCARE PROVIDER (HCP) WAS OUT OF TOWN AND WAS WORRIED THAT PATIENT HAS A LEAD FRACTURE. IT WAS ADDED THAT THE HOSPITAL WOULD BE CONTACTED TODAY TO GET PATIENT IN TO HAVE THE DEVICE INTERROGATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT AS BATTERY DRAIN AND IT WAS NOTED AS NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE DEVICE WOULD BE REPLACED ON (B)(6) 2013. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299300 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR