BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5359774 · Received January 12, 2016

    Report

    Report Number
    3004209178-2016-00372
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Report Date
    October 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-40, LOT# V641328, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V853915, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT EXPERIENCED INCREASED SIDE EFFECTS WITH TINGLING AND DYSKINESIAS. HE NEEDED TO TURN HIS SYSTEM DOWN FROM THE PREVIOUS SETTINGS. IMPEDANCE CHECKS WERE DONE IN CLINIC TO TROUBLESHOOT. NO ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE THE HIGH IMPEDANCES AND THE CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A MANUFACTURING REPRESENTATIVE REPORTED THAT A PATIENT WHOSE INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS HAD IMPEDANCE WITH PRIMARY CELL DEVICE FROM (B)(6) 2014 WHICH WERE AS FOLLOWS: C/8 AROUND 1456, C/9-4200, C/10-4077, C/11-3163, 8/9-4798, 8/10 - IN 4000S, 8/11- IN 4000S, 9/10-8971, 9/11-7500, 10/11-7300, C/0-1485, C/1-1457, C/2-2724, C/3-2469, 0/1-2001, 0/2-3680, 0/3-3534, 1/2-3416, 1/3-3416 AND 2/3-4486. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION ABOUT SYMPTOMS, TROUBLESHOOTING, ACTIONS/INTERVENTIONS TAKEN AND CAUSE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20926 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR