BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3090357 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07224
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V143392, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V143392, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED, THE CAUSE OF THE EVENT WAS ¿UNKNOWN.¿ THE PATIENT¿S PHYSICIAN REPORTED THAT ON 2013 (B)(6), HE ¿TURNED ON¿ THE PATIENT¿S STIMULATOR AND IT ¿WORKED.¿ IT WAS NOTED THAT NO SURGICAL INTERVENTION WAS REQUIRED AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS ADDITIONALLY NOTED THE ¿PATIENT RECOVERED WITHOUT SEQUELAE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) "TURNED ITSELF OFF FOR NO REASON." IT WAS NOTED THAT IT OCCURRED A "COUPLE WEEKS" PRIOR TO THE REPORT. THE PATIENT REPORTEDLY MET WITH THE HEALTHCARE PROVIDER (HCP) TO GET DEVICE CHECKED OUT AND IT WAS DETERMINED THAT THE LEFT IMPLANT WAS "OK." IT WAS NOTED THAT THE INS TURNED OFF WITHOUT THE PROGRAMMER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192258 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1