BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3030401 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04463
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3387S-40 LOT# V149608, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN MRI WAS DONE ON (B)(6) 2013 WHICH REVEALED THE LEAD MAY NOT HAVE BEEN PLACED EXACTLY WHERE IT SHOULD HAVE BEEN DURING IMPLANT; "IT WAS JUST A LITTLE OFF". A BATTERY REPLACEMENT WAS SCHEDULED FOR (B)(6) 2013 AS THE IMPLANTABLE NEUROSTIMULATOR HAD REACHED THE ELECTIVE-REPLACEMENT-INDICATOR (ERI). IT WAS UNCLEAR IF THE LEAD WAS GOING TO BE REVISED DURING THAT PROCEDURE OR IF THE LEAD REVISION WAS A SEPARATELY SCHEDULED PROCEDURE. NO FURTHER DETAILS WERE AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A NEW LEAD WAS PLACED ON (B)(6) 2013, AND IT WAS NOTED THE OLD LEAD WAS LEFT IN PLACE AND WAS STILL IN USE. THE PATIENT ONLY HAD ONE PROGRAMMING SESSION SINCE THE SECOND LEAD WAS PLACED AND IT WAS NOTED THERE WERE NO SIGNIFICANT CHANGES TO IMBALANCE, SLURRED SPEECH, OR TREMORS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133943 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention