BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2853282 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-11001
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 5, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# J0424784V, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD HIGH IMPEDANCES AND SOME, THOUGH NOT A SIGNIFICANT, DECREASE IN THERAPEUTIC EFFECT. IT WAS NOTED THAT THE IMPEDANCES FROM (B)(6) 2012 WERE ALL 'OK' WITH EXCEPTION TO ONE. IT WAS REPORTED THAT THE CASE-TO-0 IMPEDANCE WAS 34741 OHMS. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVEN WAS A LEAD FRACTURE. IT WAS ALSO NOTED THERE WERE OUT OF RANGE IMPEDANCES FOR C+0, 0+2, 0+3, AND C+3. NO REVISION HAD OCCURRED. X-RAY CONFIRMED BREAK. IT WAS ALSO NOTED THE PATIENT HAD BILATERAL FRACTURE AND THAT THE PATIENT HAD BEEN ASYMPTOMATIC FOR YEARS UNTIL THIS EVENT. PATIENT WAS REPROGRAMMED, THEY CHANGED FROM MONOPOLAR TO BIPOLAR CONFIGURATION AND IT IMPROVED THE SHOCK-LIKE SENSATIONS. SIGNS AND SYMPTOMS INCLUDE SHOCKING SENSATION. THERE WAS NO HOSPITALIZATION REQUIRED DUE TO THE EVENT. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE-TO-0 IMPEDANCE WAS 3471 OHMS, NOT 34741 OHMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1