BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 3396118 · Received October 9, 2013

    Report

    Report Number
    3004209178-2013-17688
    Event Type
    Death
    Date Received
    October 9, 2013
    Report Date
    September 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37603 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2011(B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389S-40 LOT# V742351, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V592416, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-60 LOT# 46).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PMA CODE WAS INCORRECT ON THE INITIAL REPORT, THE CORRECT PMA CODE IS P960009.

    Description of Event or Problem · 1

    PLEASE REFER TO MANUFACTURES REPORT # 3004209178-2013-17689 FOR ADDITIONAL INFORMATION ON A RELATED DEVICE.

    Description of Event or Problem · 1

    2013 (B)(6) ((B)(4)): IT WAS REPORTED THAT THERE WAS A PATIENT DEATH. THE DATE OF DEATH WAS REPORTED AS 2013 (B)(6). IT WAS NOTED THAT BOTH THE DEEP BRAIN STIMULATION (DBS) DEVICES WERE REMOVED ON 2013 (B)(6) DUE TO INFECTION. THE DOCTOR REPORTEDLY CUT THE EXTENSIONS ABOVE THE CONNECTOR IN AN EFFORT TO SAVE THE LEADS SO HE COULD RE-IMPLANT LATER. IT WAS NOTED THAT THE PATIENT WAS OLDER AND HAD OTHER CO-MORBIDITIES BUT IT WAS NOT KNOWN WHAT THEY WERE. THE PATIENT REPORTEDLY ASPIRATED AND THAT WAS WHAT CAUSED THE DEATH. IT WAS ALSO MENTIONED THAT THE DOCTOR THOUGHT THAT THE PATIENT GOT SO MUCH BENEFIT FROM THE DBS THAT WHEN THERAPY WAS STOPPED, DUE TO THE EXPLANTS, THE PATIENT HAD SUCH ADVANCED PARKINSON¿S DISEASE THAT THE SYMPTOMS ESCALATED WITHOUT STIMULATION. IT WAS NOTED THAT THEY ATTEMPTED TO MANAGE THE PATIENT¿S SYMPTOMS WITH MEDS BUT IT DID NOT WORK. 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 THAT THERE WAS A CULTURE DONE AND THE RESULTS WERE (B)(6). IT WAS NOTED THAT THE LOCATION OF THE INFECTION WAS THE BILATERAL CHEST WALL. IT WAS FURTHER NOTED THAT THE CAUSE WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512740 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death| R