BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5499254 · Received March 14, 2016

    Report

    Report Number
    9614453-2016-01625
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    May 8, 2014
    Report Date
    September 29, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 338728, LOT# B0851822K, IMPLANTED: (B)(6) 2008-, EXPLANTED: (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HOSPITALIZED FOR AN ELECTRODE MAPPING TO FIND BETTER STIMULATION PARAMETERS. THERE WAS NO SOLUTION FOUND TO DECREASE THE TREMOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT OCCURRED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE PATIENT EXPERIENCED INCREASED OF TREMOR. BEFORE THE PATIENT'S OFFICE VISIT THE STIMULATION PARAMETER CHANGED BECAUSE OF TREMOR INCREASE. NO DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED AS A RESULT OF THE EVENT. THE PATIENT WAS REPROGRAMMED. THE EVENT WAS PROGRAMMING/STIMULATION RELATED. THE EVENT WAS NOT SERIOUS. ADDITIONAL INFORMATION RECEIVED FROM AN HCP FOR A CLINICAL STUDY REPORTED THE RIGHT ARM AND HEAD HAD AN INCREASE IN TREMOR WHEN STIMULATION PARAMETERS INCREASED THEN EXPERIENCED WORSENING OF DYSARTHRIA. IT WAS REPORTED THE LEAD WAS EXPLANTED ON (B)(6) 2015. HOWEVER, IT WAS LATER UPDATED THAT AN EXAMINATION WAS CONDUCTED ON (B)(6) 2015 AND THE LEAD WAS EXPLANTED ON (B)(6) 2015; THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. FOLLOW-UP WAS CONDUCTED TO OBTAIN ADDITIONAL INFORMATION INCLUDING CAUSE AND DIAGNOSTICS/TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155132 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R