BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3143218 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08563
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    April 22, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIM ULATOR; 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 3389S-40, LOT# VA0501U, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA0501U, PRODUCT TYPE LEAD; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A PAIN ¿IN BETWEEN HIS TWO IMPLANTS¿ AND AT ONE POINT THE LEFT ONE GOT ¿VERY HOT VERY BRIEFLY.¿ IT WAS STATED THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE HE THOUGHT THIS PAIN HE WAS FEELING WAS A HEART ATTACK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNCLEAR IF AN ALLERGIC REACTION WAS THE CAUSE OF THE EVENT. THE PATIENT WAS REPORTEDLY HOSPITALIZED FOR ONE DAY PUT ON ANTIBIOTICS FOR 24 HOURS. IT WAS STATED THAT THE PATIENT HAD A LOT OF ANXIETY. THERE WAS NO SURGICAL INTERVENTION PERFORMED. PLEASE REFER TO MFG. REPORT # 3004209178-2013-08562, AS THIS REPORT PERTAINS TO THE PATIENT¿S RIGHT IMPLANT.

    Description of Event or Problem · 1

    THIS WAS BILATERAL SYSTEM. REFERENCE MFR 3004209178-2013-08562.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244876 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization