BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1851144 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07501
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A PT UNDERWENT A CATHETER REVISION FOLLOWING A FALL WHICH HAD CAUSED THE PT TO FEEL AN INCREASE OF PAIN. THE PT HAD DEVELOPED A SEROMA AROUND THE PUMP WHICH WAS LOCATED IN THE LEFT ABDOMINAL AREA. THE SEROMA WAS NOTED AS BEING DRAINED TWICE, WITH ONE/BOTH OF THE DRAINING PROCEDURES OCCURRING ON (B)(6)2010. PRIOR TO THE LEAD REVISION, THE PT'S DOSE WAS REDUCED TO 1.5 MG/DAY OF DILAUDID (25MG/ML) AND 0.0882 MG/DAY OF BUPIVICAINE (14.7 MG/ML). A FLUORO TEST ON (B)(6)2010, REVEALED THAT THE CATHETER HAD MOVED OUT OF THE SPINE AND WAS SITTING IN THE TISSUE. IT WAS NOTED THAT PART OF THE CATHETER WAS REMOVED, BUT THE TUNNEL SECTION WAS LEFT IN PLACE DUE TO DIFFICULTY WITH LOCATING THE CATHETER. A NEW CATHETER WAS PLACED, AND WAS DOUBLE ANCHORED USING V-WING ANCHORS. GOOD CEREBRAL SPINAL FLUID FLOW WAS NOTED AS BEING AT EVERY STEP OF THE IMPLANT. THE PUMP POCKET WAS OPENED, AND WAS FOUND TO HAVE HAD A HEMATOMA PRESENT. A SMALL AREA OF WHITE DRAINAGE WAS PRESENT, AND A SAMPLE TAKEN TO DETERMINE A CULTURE. THE SURROUNDING TISSUE WAS EXCISED. THE REST OF THE TISSUE WAS NOTED AS BEING PINK, WITHOUT ANY OTHER SIGNS OF INFECTION. ANTIBIOTICS WERE GIVEN DURING THE PROCEDURE. THE PT STAYED AT THE HOSPITAL OVERNIGHT FOR OBSERVATION, AND WAS NOTED AS DOING WELL. NO FURTHER SIGNS/SYMPTOMS OF INFECTION HAD OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N255703002| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG017322N| EXPLANTED:| EXPLANTED: