BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113733 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03930
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    September 24, 2010
    Report Date
    May 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE PATIENT ARRIVED TO THE HOSPITAL ON (B)(6) 2010, WITH REDNESS AND CLEAR DRAINAGE PRESENT FROM THE PUMP SITE. THE AREA CONTAINED CELLULITIS AND ERYTHEMA. THE HCP HAD THOUGHT THE REACTION WAS TO SILICONE; WHICH IS CONSISTENT IN THE PATIENT'S PUMP. THE PATIENT UNDERWENT ALLERGY TESTING AND TESTED (B)(6). AS A RESULT OF THE REACTION, THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED. THE PATIENT DEVELOPED A POST-SPINAL HEADACHE AFTER HER INTRATHECAL CATHETER WAS REMOVED. SHE WAS TREATED CONSERVATIVELY WITH FLUIDS AND CAFFEINE, WHICH WERE UNSUCCESSFUL. THE PATIENT WAS TREATED WITH A BLOOD PATCH ON (B)(6) 2010, WHICH SUCCESSFULLY IMPROVED HER HEADACHE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2010. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVACAINE, CLONIDINE, AND HYDROMORPHONE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 53 YR Other| R CATHETER: MODEL 8731SC, LOT# N205631007| EXPLANTED:| IMPLANTED: