BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2003724 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01419
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED ON A VENTILATOR FOLLOWING A 40 MIN SEIZURE. THE PT WAS LAST SEEN IN THE CLINIC FOR A 15% INCREASE ON (B)(6) 2011. A "BUMP" WAS NOTED ON PT'S BACK AT THE CATHETER SITE AND AN XRAY WAS DONE CONFIRMING APPROPRIATE PLACEMENT. THE HCP REPORTED THAT THE PT'S "SYMPTOMS ARE LIKELY NOT A RESULT OF THE INFUSION SYSTEM AND THEY'RE CONTINUING TO MONITOR AND INVESTIGATE CAUSES". THE HCP LATER REPORTED THAT THE PT WAS PUT ON "COMFORT CARE ONLY/END OF LIFE MEASURES DUE TO AN ANOXIC BRAIN SECONDARY TO A 40 MIN SEIZURE EVENT THAT OCCURRED LAST WEEK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L| R CATHETER: MODEL 8709SC, LOT# N259139013| IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N236433| IMPLANTED: