BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4267824 · Received November 21, 2014

    Report

    Report Number
    9614453-2014-02613
    Event Type
    Injury
    Date Received
    November 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 924256, LOT# 082229013A, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3389-40, LOT# 0208192864, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# 0208340642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6)2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3755-40, LOT# 0207961372, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE CORYNEBACTERIUM STRIATUM WAS CULTURED FROM THE PATIENT¿S ¿BATTERY POCKET¿ AND ¿LIQUID CONNECTORS¿ ON (B)(6) 2014 AND WAS FOUND TO HAVE ANTIBIOTIC RESISTANCE TO DOXY, GENTA, LINEZOLID, RIFAMPICIN, AND VANCO. ADDITIONALLY, KNS WAS CULTURED FROM THE EXTENSION IN THE PATIENT¿S LEFT HEAD AND STAP. AUREUS FROM EXUDATE FROM THE PATIENT¿S LEFT EAR ON (B)(6) 2014. BOTH BACTERIUM WERE FOUND TO HAVE HAD A ¿USUAL RESISTANCE¿ PROFILE. AS A RESULT, THE PATIENT WAS ADMINISTERED CLAFORAN AND VANCO. THE PATIENT¿S SYSTEM WAS A NEW IMPLANT FOR THE PATIENT WHEN IT WAS INITIALLY IMPLANTED. IT WAS NOTED THE PATIENT RETURNED HOME TWO DAYS AFTER THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ESSENTIAL TREMOR PATIENT¿S SYSTEM WAS EXPLANTED DUE TO AN INFECTION. CULTURES WERE TAKEN FROM THE PATIENT WERE FOUND TO CONTAIN THE BACTERIUMS ¿STAF. AUREUS,¿ CORYNEBACTERIUM STRIATUM, AND ¿KNS.¿ THE PATIENT WAS ADMINISTERED ANTIBIOTICS IN TREATMENT FOR THEIR INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT¿S SYMPTOMS, INTERVENTION, AND OUTCOME. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755605 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R