BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2230772 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06695
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    October 1, 2009
    Report Date
    July 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT HAD A KINETRA (B)(4) REPLACED WITH AN ACTIVA (B)(4) IN (B)(6) 2009. THE FOLLOW-UP DETECTED ABNORMAL HIGH IMPEDANCES FOR ALL CONTACTS ON THE RIGHT SIDE. THE SYSTEM WAS CHECKED SURGICALLY IN (B)(6) 2011 AND THE IMPEDANCES ON THE RIGHT SIDE WERE VERY HIGH, EVEN AFTER THE LEAD EXTENSIONS WERE CHANGED FROM ONE CHANNEL TO THE OTHER. A PROBLEM WITH THE INS WAS SUSPECTED AND IT WAS EXPLANTED AND REPLACED. IT WAS REPORTED THAT AFTER SURGERY A PROGRAMMING ERROR OF THE ACTIVA AROSE AS THE PROBABLE EXPLANATION OF THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention UNK.