BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1960941 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-00252
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A PUMP REPLACEMENT AND CATHETER REVISION ON (B)(6) 2010 (SEE MFR'S REPORT #3004209178-2011-00250), THE PATIENT DEVELOPED A SEVERE HEADACHE. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2011. AN INCISION WAS MADE OVER THE SITE OF THE CATHETER IMPLANT LOCATION AND APPROX 5 CC OF SPINAL FLUID WAS FOUND. IT WAS DETERMINED THAT THERE WAS A LEAK AROUND THE CATHETER INSERTION SITE. THE PHYSICIAN DID A PURSE STRING AROUND THE CATHETER INSERTION SITE AND DID NOT REPLACE THE INTACT CATHETER. THE PHYSICIAN NOTED THAT HE DID NOT PUT A PURSE STRING AROUND THE OPENING WHEN HE IMPLANTED THE CATHETER ON (B)(6) 2010. THE PATIENT WAS GOING TO BE DISCHARGED TO HOME THE SAME DAY FOLLOWING A BRIEF TIME IN THE RECOVERY ROOM AND SHORT STAY UNIT. THE PHYSICIAN WAS HOPING THE REVISION WOULD FIX THE PATIENT'S HEADACHE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 48 YR Other EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N236676009| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40| LOT# NGV430107H| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N272915003