BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3512883 · Received December 10, 2013

    Report

    Report Number
    3004209178-2013-23153
    Event Type
    Injury
    Date Received
    December 10, 2013
    Report Date
    November 22, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT # V113842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V508018, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PROGRAMMER SHOWED ERI TODAY. IT WAS ALSO REPORTED THE PATIENT HAD BEEN HAVING AN INCREASE IN SPASMS, SEE FLOATERS OR SPOTS FOR VISIONS, AND LOSING HER BALANCE SINCE (B)(6) 2013. SPEECH ISSUES WERE ALSO NOTED. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THE CAUSE OF THE EVENT WAS AN "EXPIRING LEFT IMPLANTABLE NEUROSTIMULATOR (INS)." IT WAS STATED THAT THE INS BATTERY DEPLETION WAS "NORMAL." THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS STATED THAT THE INS WAS REPLACED ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT DID REQUIRE HOSPITALIZATION AND THAT IT WAS AN "OUTPATIENT PROCEDURE." THE PATIENT OUTCOME WAS REPORTED AT "NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643392 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization