BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4563332 · Received March 3, 2015

    Report

    Report Number
    3004209178-2015-03977
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Report Date
    February 8, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# L64602, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE REPLACEMENT THE PATIENT ONLY HAD A COUPLE OF EVENTS OF TINGLING, SHOCKING SENSATION IN THE BACK OF THE HEAD, ARM, AND ALL OVER HIS BODY, AND A RUSHING FEELING IN HIS HEAD. HE ALSO HAD A LOSS OF THERAPEUTIC EFFECT FROM THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS), WHICH BEGAN IN (B)(6) 2013. IMPEDANCES WERE MEASURED AND ALL WERE WITHIN RANGE. THE ELECTRODE COMBINATIONS OF CASE AND 0 (2,054 OHMS) AND CASE AND 3 (2,217 OHMS) WERE A LITTLE HIGH, BUT NOT CLEAR OPENS. THE PATIENT WAS NOT GETTING ANY THERAPY OR SIDE EFFECTS ON THE DAY OF THE REPORT WHEN REPROGRAMMED, EVEN WHEN STIMULATION WAS UP TO 5, 6, OR EVENT 9 VOLTS. HE DID NOT FEEL ANYTHING WHEN THE IMPEDANCES WERE CHECKED AS WELL. UP UNTIL NOW, THEY HAD BEEN THINKING THE ISSUE WAS RELATED TO THE PROGRAMMING, BUT THEY TRIED ALL PAIRS AND DID NOT GET A RESPONSE. THE LEAD HAD NOT BEEN IMAGED YET AND THE RIGHT SIDE INS WAS FINE. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147720 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1