BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4267825 · Received November 21, 2014

    Report

    Report Number
    9614453-2014-02614
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID NEU_UNKNOWN_EXT, IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD,IMPLANTED: 2012-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_EXT, IMPLANTED: 2012-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: 2012-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 64002, LOT# 205835708, PRODUCT TYPE ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ESSENTIAL TREMOR PATIENT¿S WHOLE SYSTEM WAS EXPLANTED DUE TO AN INFECTION. CULTURES WERE TAKEN FROM THE PATIENT WERE FOUND TO CONTAIN THE BACTERIUMS ¿STAF. EPIDERMIS,¿ ¿CORYNEBACTERIER,¿ AND ¿KNS.¿ THE PATIENT WAS ADMINISTERED ANTIBIOTICS IN TREATMENT FOR THEIR INFECTION. IT WAS NOTED THE PATIENT HAD EXPERIENCED A ¿WOUND HEALING DISTURBANCE.¿ IT WAS ALSO NOTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿SUPERFICIAL¿ DUE TO ¿NO FAT.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT¿S SYMPTOMS, INTERVENTION, AND OUTCOME. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE CORYNEBACTERIA WAS CULTURED FROM EXUDATE ON (B)(6) 2014 AND FOUND TO HAVE ANTIBIOTIC RESISTANCE TO ¿ALL EXCEPT KLINDA,¿ THE KNS WAS ALSO CULTURED FROM EXUDATE ON (B)(6) 2014 AND WAS FOUND TO HAVE ANTIBIOTIC RESISTANCE TO ¿ALL EXCEPT FUCI, TOBRA, AND POG,¿ AND THE STAPH. EPIDERMIDIS WAS CULTURED FROM THE TISSUE BOX AND WAS FOUND TO HAVE ANTIBIOTIC RESISTANCE TO ¿LINEZOLID, VANCO, AND RIFAMPICIN.¿ THE PATIENT WAS ADMINISTERED HERACILLIN FROM (B)(6) 2014 AND FROM (B)(6) 2014. A BACTERIAL CULTURE WAS TAKEN FROM A PATIENT ACQUIRED TISSUE CULTURE ON (B)(6) 2014 AND AFTER UNDERGOING A ¿POLYMERASE CHAIN REACTION (PCR) ON EXSTRIP¿ WAS FOUND TO HAVE TESTED NEGATIVE FOR BACTERIAL INFECTION. THE PATIENT¿S SYSTEM WAS NOTED TO HAVE BEEN A REPLACEMENT SYSTEM WHEN IT WAS INITIALLY IMPLANTED. THE PATIENT WAS REPORTEDLY ¿NOT WORSE WITHOUT THE SYSTEM¿ FOLLOWING THE EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED ¿THIS PATIENT HAD SOME KIND OF IMMUNOSUPPRESSIVE DISORDER AS WELL¿ AND THAT THEIR HEALTHCARE PROVIDERS (HCPS) ¿SUSPECTED SHE GOT A LATE INFECTION DUE TO THIS.¿ IT WAS ALSO NOTED THE HOSPITAL ¿DID NOT CHANGE ANY PREP PROCEDURES¿ PRIOR TO THE INITIAL IMPLANT OF THE PATIENT¿S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756709 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R