BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3800708 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08754
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 21, 2014
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0125010V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# J0225421V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0125010V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# J0225421V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN END OF SERVICE (EOS) MESSAGE. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS AT EOS AND DEFECTIVE. IT WAS NOTED THE SETTINGS OR IMPEDANCES WERE NOT KNOWN AT THE TIME OF REPORT. IT WAS STATED THEY DID NOT KNOW WHEN THE EOS APPEARED. IT WAS FURTHER REPORTED THE PATIENT HAD A SHORT IN THEIR SYSTEM DUE TO THE USE OF THE PATIENT¿S GLASSES. IT WAS NOTED THE PATIENT¿S SYSTEM WAS IMPLANTED ABOUT 10 YEARS PRIOR TO REPORT AND THEY HAD ALWAYS WORN A PAIR OF GLASSES THAT HAD PRESSED RIGHT UP AGAINST THE LEAD/EXTENSION CONNECTION. IT WAS NOTED THEY COULD SEE THE DAMAGED AREA THROUGH THE SKIN. IT WAS NOTED THE SYSTEM WAS CHECKED AND A SHORT WAS EVIDENT. IT WAS STATED THE PATIENT WOULD FOLLOW UP WITH THEIR SURGEON AND PREPARE FOR A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278713 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention