BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3688348 · Received March 19, 2014

    Report

    Report Number
    3004209178-2014-04640
    Event Type
    Injury
    Date Received
    March 19, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 64002 LOT# N268813, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER; PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387-40, LOT# V002359, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387-40, LOT# V002359, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 37092, LOT# 236730002, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID: 3387-40, LOT# V002359, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE TO AN INFECTION. IT WAS STATED THE PATIENT'S RIGHT POCKET LOOKED SWOLLEN AND RED. IT WAS NOTED THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS FURTHER REPORTED THERE WAS NO CULTURE INFORMATION AVAILABLE AND THE PATIENT DID NOT RECEIVE EFFECTIVE DEEP BRAIN STIMULATOR (DBS) THERAPY AT THE TIME OF REPORT BECAUSE THE ENTIRE SYSTEM WAS EXPLANTED DUE TO THE INFECTION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT RECEIVED BOTH IV AND ORAL ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNKNOWN IF PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. IT WAS NOTED THE PATIENT DID NOT HAVE MENINGITIS. IT WAS STATED THERE WAS REDNESS AND DRAINAGE. IT WAS NOTED THE PRIMARY LOCATION OF INFECTION WAS AT THE DEVICE POCKET. IT WAS NOTED A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND BLOOD. IT WAS STATED THE TYPE OF ORGANISM THAT WAS CULTURED WAS UNKNOWN. IT WAS STATED THE PATIENT HAD IV ANTIBIOTICS AND A TOTAL DEVICE SYSTEM EXPLANT. IT WAS NOTED THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164257 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention