BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2923365 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00780
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 64002, LOT# N242884, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ADAPTER: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V130326, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V130326, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V427154, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V427154, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SYMPTOMS OF REDNESS, SWELLING, PAIN AND A BLISTER AREA BEHIND THE RIGHT EAR. IT WAS STATED THAT THERE WAS SWELLING AND PAIN OVER THE RIGHT BURR HOLE ON (B)(6) 2012. THE PRIMARY LOCATION OF INFECTION WAS THE LEAD TRACK. IT WAS REPORTED THAT THE INFECTION WAS DIAGNOSED ON (B)(6) 2012 AND THE PATIENT WAS STARTED ON ORAL AND INTRAMUSCULAR ANTIBIOTICS. IT WAS NOTED THAT NO CULTURE WAS OBTAINED. IT WAS REPORTED, THE PATIENT'S INFECTION WAS RESOLVED AS OF (B)(6) 2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A BLISTER BEHIND THEIR EAR TWO DAYS AGO. THE LOCATION OF THE BLISTER WAS STATED AS "RIGHT ON TOP OF THE WIRE." THE PATIENT WENT TO THE EMERGENCY ROOM THE PREVIOUS NIGHT, AS OF THE DATE OF THIS REPORT. IT WAS STATED THE BLISTER WAS LANCED AT THAT POINT. THE PATIENT ALSO REFERRED TO THE BLISTER AS AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF EVENT WAS UNKNOWN INFECTION. THE DEVICE WAS REPLACED. HOSPITALIZATION WAS REQUIRED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30499 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R