BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3039934 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04830
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED CONCLUSION NO LONGER APPLY TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT # L69546, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # J0118277V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THE RIGHT HEMISPHERE SYSTEM EXPLANTED BECAUSE THE PATIENT HAD MOHS SURGERY TO REMOVE A SKIN TUMOR OVER THE IMPLANT. IT WAS NOTED THE SYSTEM WAS EXPLANTED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT HEMISPHERE LEAD, EXTENSION, AND IMPLANTABLE NEUROSTIMULATOR WERE EXPLANTED. THE EXPLANT WAS RELATED TO SKIN BREAKDOWN BY THE LEAD RELATED TO A MOHS PROCEDURE NEAR THAT AREA. 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
    144056 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention