BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3111828 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07629
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40 LOT# VA00UCG, IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3387S-40 LOT# VA07SQ6, IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT'S DEVICE SYSTEM WAS REMOVED DUE TO AN INFECTION. THE PATIENT EXPERIENCED DRAINAGE AND/OR INCISIONAL WOUND OPENING. IT WAS NOTED, THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED A DAY LATER REPORTED IT WAS UNKNOWN IF CULTURES WERE DONE. THE LOCATION OF THE INFECTION WAS THE LEFT CRANIAL DEEP BRAIN STIMULATION (DBS) INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A FEW WEEKS AFTER HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) PUT IN THE PATIENT HAD AN INFECTION. IT WAS NOTED THAT SHE WAS IN THE HOSPITAL FOR A WEEK AND WAS ON MEDICATION AND AN IV BECAUSE OF THE INFECTION. IT WAS REPORTED THAT THE DEVICE WAS REMOVED IN "(B)(6) OF 2013" AND THE PATIENT HAD A HARD TIME REMEMBERING DATES. THE PATIENT HAD A DEVICE RE-IMPLANTED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213351 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R