BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3833392 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09637
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. THE PATIENT WAS SEEN 1-2 DAYS PRIOR TO THE DATE OF THIS REPORT BY THE NEUROSURGEON. THE PATIENT HAD PRESENTED IN THE EMERGENCY ROOM ON THE DATE OF THIS REPORT. IT WAS NOTED THAT THERE WAS A POSSIBLE INFECTION ON ONE OF THE EXTENSIONS. IT WAS UNKNOWN WHICH EXTENSION. THE PATIENT WAS BEING TAKEN INTO SURGERY WHERE THEY PLANNED TO CLEAN IT OUT AND THEY WERE NOT PLANNING ON EXPLANTING ANY EQUIPMENT AT THAT TIME. IT WAS LATER REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM ON (B)(6) 2014 AND THE PATIENT WAS HAVING THE BATTERY AND EXTENSION REMOVED BECAUSE OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-09632.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFORMATION PREVIOUSLY REPORTED UNDER THIS MANUFACTURER¿S REPORT NUMBER ONLY PERT AINS TO THE RIGHT SIDE DEVICES. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-09632.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT HAD MET WITH THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2014 AND STILL HAD THE INFECTION. THE PATIENT WENT INTO THE OPERATING ROOM AND THE HCP REMOVED THE EXTENSION CONNECTOR AND LEFT THE LEAD IN PLACE WITHOUT A BOOT. IT WAS NOTED THAT THEY WERE WAITING FOR THE INFECTION TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310882 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention