BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093622 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03471
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BEEN IN A NURSING HOME DUE TO A TRAUMATIC BRAIN INJURY. THE PT HAD BEEN HAVING FEVERS THAT RANGED IN TEMPERATURE FROM 99-103.9 DEGREES FOR THE PAST 11 DAYS. IT WAS NOT KNOWN IF THERE WAS AN INFECTION, BUT IT WAS THOUGHT THAT THERE MAY HAVE BEEN A "BACLOFEN INFECTION" AT THE PUMP SITE. THE SKIN AROUND THE PUMP WAS INTACT AND NO OTHER INFECTIONS HAD BEEN FOUND ANYWHERE ELSE ON THE PT. THE PT'S ABDOMEN WAS DISTENDED. SURGERY HAD BEEN PERFORMED TO CHECK THE BOWELS ON (B)(6) 2011. THE DOCTOR REMOVED THE PT'S APPENDIX. THE PT WAS IN ICU AND WAS ON A VENTILATOR FOLLOWING THE SURGERY. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 37 YR Required Intervention CATHETER: MODEL 8709SC, LOT # N256226007| EXPLANTED:| IMPLANTED: