BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3499364 · Received December 4, 2013

    Report

    Report Number
    3004209178-2013-21897
    Event Type
    Injury
    Date Received
    December 4, 2013
    Report Date
    November 19, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37642 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40 LOT# V230077, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7438, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40 LOT# V248436, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THE EXTENSION WAS CLIPPED POSTERIOR TO THE ¿ER LOBE¿ TO MINIMIZE THE POSSIBLE SPREAD OF THE INFECTION TO THE LEAD WIRE. IT WAS FURTHER NOTED THE LEAD AND EXTENSION CONNECTION REMAINED INTACT. IT WAS NOTED, THE INFECTION WAS AT THE DEVICE POCKET AND THE TYPE OF INFECTION WAS UNKNOWN. IT WAS FURTHER NOTED THAT CULTURES WERE TAKEN FROM THE PATIENT¿S BLOOD AND DEVICE POCKET. THE REPORTER STATED, THE INFECTION WAS DIAGNOSED ON 2013 (B)(6). IT WAS NOTED THE PATIENT HAD REDNESS AT THE DEVICE POCKET. IT WAS FURTHER NOTED, THE PATIENT WAS HOSPITALIZED AND ANTIBIOTIC TREATMENT WAS NECESSARY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627972 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R