BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4201869 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20390
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 21, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ON 8/21/14 THE HCP WENT TO DO THE PATIENT'S FIRST REFILL. WHEN THE HCP LOOKED AT THE SKIN AND THE SKIN WAS YELLOW, CRUSTY, WHITE SCABBY PLAGUE. THE SKIN WAS REALLY THIN. THE HCP BRUSHED IT LIGHTLY WITH A KLEENEX AND SKIN WAS FLAKING OFF, LIGHTLY BLOODY BUT JUST FLAKING OFF. PER THE HCP THE ODD THING WAS THE SKIN THAT WAS FLAKING OFF WAS OVER THE PUMP, IN A CIRCLE IN THE AREA OF THE PUMP. A REALLY ODD REACTION BECAUSE THE SKIN EVERYWHERE ELSE WAS FINE. THE HCP DECIDED NOT TO DO THE REFILL AND INSTEAD HAD THE PATIENT ADMITTED. NO NEEDLE HAD BEEN TOUCHED TO HIM SINCE IMPLANT. THE SKIN IN THE EXACT SHAPE OF THE PUMP WAS ALL RED, SCABBY AND THE HCP STATED SHE WASN'T GOING TO STICK A NEEDLE INTO THAT UNTIL SHE HAD ID (INFECTIOUS DISEASE) OR DERM (DERMATOLOGY) LOOK AT THE SITE. THE NEXT DAY (8/22/14) DERMATOLOGY LOOKED THE PATIENT AND DETERMINED IT WAS A CONTACT DERMATITIS AND IT WAS NOT INFECTIOUS. THE PATIENT WAS PROVIDED WITH A CREAM AND THE SITE WAS HEALING REALLY NICELY SINCE THE CREAM WAS STARTED. THE MEDICATION WAS NOT TO TREAT ALLERGY BUT WAS FOR THE DERMATITIS. PER THE HCP THE SITE LOOKED MUCH BETTER. NOTHING WAS PUT ON THE SITE AND THE PATIENT DID NOT USE A SEATBELT IN THE WHEELCHAIR THAT COULD EXPLAIN THE CONTACT DERMATITIS. PER THE HCP THE SPECIALISTS DETERMINED THE PATIENT HAD AN ALLERGIC CONTACT DERMATITIS. THE HCP ALSO STATED THAT THE PATIENT WAS DOING REALLY WELL WITH THE PUMP. THE PATIENT WAS AFRICAN AMERICAN AND THE SKIN HAD "BLANCHED" IN THE AREA OF THE DERMATITIS BUT PER THE HCP HOPEFULLY THE SKIN WOULD GET ITS COLOR BACK EVENTUALLY THAT THE CREAM WAS HEALING THE AREA. THE HCP ALSO STATED THAT IT WAS ¿JUST ODD BECAUSE THE SKIN WAS FLAKING OFF IN PIECES¿ AND ¿A VERY ODD REACTION SOME MANY MONTHS AFTER IMPLANT¿. THERE WAS NOTHING WRONG WITH THE EQUIPMENT OR THE PUMP. THE PUMP WAS USED TO DELIVER BACLOFEN. NO OUTCOME WAS REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN THE INFORMATION. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681998 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization