BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3821354 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09277
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# VA02KCE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA01ER8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37092, LOT# 359340001, IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED INTRA-OPERATIVE IMPEDANCES SHOWED A SHORT CIRCUIT BETWEEN 3 AND 2. IT WAS FURTHER REPORTED THE IMPEDANCES WERE RE-CHECKED AFTER THE REPLACEMENT AND IT STILL SHOWED A LOW OR SHORT CIRCUIT BETWEEN CONTACT 2 AND 3. IT WAS STATED THE PATIENT HAD BEEN AND STILL USED CONTACT 3 AND 2 WITH 5.2V FOR THERAPY CONTROL. IT WAS NOTED THE PATIENT RECEIVED THERAPY AFTER THE GENERATOR CHANGE DESPITE THE SHORT CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300160 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR