BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1902228 · Received November 15, 2010

    Report

    Report Number
    3004209178-2010-09528
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    October 22, 2010
    Report Date
    March 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SLEEP WALKING AND FELL; THE PUMP BECAME DISLODGED FROM THEIR SUTURES. IT WAS NOTED THAT THE PUMP WAS FLIPPING IN THE WOUND. THE PUMP CONTAINED 20.0 MG/ML OF BUPIVACAINE WITH 15.014 MG/DAY DOSAGE; 200 MCG/ML OF FENTANYL WITH 900.8 MCG/DAY; 1000 MCG/ML OF CLONIDINE WITH 750.7 MCG/DAY; AND 150.0 MCG/ML OF BACLOFEN WITH DOSES OF 112.60 MCG/DAY. ON (B)(6) 2010, THE DEVICE WAS SURGICALLY REPOSITIONED. THE OUTCOME WAS NOTED AS ONGOING. ADDITIONAL INFORMATION RECEIVED INDICATED THE DRUG IN THE PUMP WAS NOTED AS BUPIVACAINE, DILAUDID, CLONIDINE AND BACLOFEN. THE BACLOFEN WAS NOTED AS 150.0 MCG/ML WITH DOSES OF 59.97 MCG/DAY, 78.26 MCG/DAY, 48.68 MCG/DAY, AND 77.29 MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT 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 Female Required Intervention CATHETER: MODEL 8709, LOT# N004905128.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N004905128| EXPLANTED:| IMPLANTED: