BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901963 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09461
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 29, 2010
    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'S CATHETER WAS REVISED AND MOVED FROM T6 TO T10 FOLLOWING A LOSS OF PAIN RELIEF. IT WAS STATED THE HEALTH CARE PROVIDER INCREASED THE PATIENT'S PUMP INFUSION RATE ON (B)(6) 2010 WITH NO RELIEF. ON (B)(6) 2010, THE PATIENT'S CATHETER WAS SPLICED AND MOVED. ON (B)(6) 2010, IT WAS REPORTED THE PATIENT RECOVERED WITHOUT SEQUELA. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE LIORESAL, PRIALT, DILAUDID, CLONIDINE, AND BUPIVICAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention CATHETER: MODEL 8709, LOT# N130963015.| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N130963015