BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2230453 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06337
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED FOLLOWING A REPLACEMENT. THE REDNESS AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPROVING SINCE THE PATIENT WENT ON ANTIBIOTICS. (B)(6). IT WAS REPORTED THE PATIENT HAD A PREVIOUS SYSTEM THAT WAS EXPLANTED DUE TO INFECTION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2011. THERE WAS NO INJURY TO THE PATIENT. REFER TO MANUFACTURER REPORT # 3004209178-2011-06341.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT AT THE TIME THAT THE DEVICE WAS IMPLANTED, 2 YEARS PRIOR TO THIS REPORT, THE PATIENT ALSO HAD A STAPH INFECTION 'IMPLANTED.' IT WAS NOTED THAT THE DEVICE 'CAME OUT, WENT IN, CAME OUT, WENT IN.' THE PATIENT HAD 7 SURGERIES IN 1 YEAR DUE TO INFECTIONS AND TAKING THE DEVICE OUT AND THE LEADS. THE PATIENT WAS ON IV ANTIBIOTICS FOR 30 DAYS, AND IT WAS THOUGHT THE PATIENT WAS FINE AFTERWARDS. THE PATIENT WAS DOING WELL FOR 'OVER A YEAR." NO SPECIFIC DATES FOR SURGERIES OR INTERVENTIONS WERE REPORTED AND IT WAS UNCLEAR WHICH COMPONENTS WERE TAKEN OUT AND WHEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R LEAD: MODEL 3387S, LOT# V553425| EXPLANTED:| LEAD: MODEL 3387S, LOT# V553427| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEUROSTIMULATOR: MODEL 37601| LOT# NKM706731H| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN013558V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN011952V| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN014001V| EXTENSION: MODEL 37085, LOT# NKN013557V| IMPLANTED:| IMPLANTED:| EXPLANTED: