BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 2950043 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00414
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT CONCLUSION CODES.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AS MANUFACTURING REPORT #3007566237. ADDITIONAL REVIEW SHOWED THE CORRECT MANUFACTURING SITE WAS SITE #3004209178.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFECTION AT THE POCKET SITE POST-OPERATIVELY. IT WAS NOTED ANTIBIOTIC TREATMENT WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INFECTION APPEARED TO HAVE BEEN TREATED WELL WITH INTRAVENOUS AND ORAL ANTIBIOTICS. THERE WAS NO SIGN OF INFECTION AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55128 ACTIVA RC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention