BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2130545 · Received June 14, 2011

    Report

    Report Number
    3004209178-2011-04418
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    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

    THE PATIENT EXPERIENCED SYMPTOMS OF OVERDOSE FOLLOWING A PUMP AND CATHETER REPLACEMENT. SEE MANUFACTURER'S REPORT #3007566237-2011-04413 FOR INFORMATION ON THE PRIOR PUMP. THE PATIENT WAS "FLOPPY" (B)(6) AFTER THE REPLACEMENT SURGERY. THE PATIENT WAS PROGRAMMED AT 200MCG/DAY OF LIORESAL AT A 2000MCG CONCENTRATION. THE HCP THEN "BUMPED IT DOWN TO 100 TO HELP WITH THE FLOPPINESS AND THAT WAS STILL NOT LOW ENOUGH." THE PUMP WAS NOW AT THE MINIMUM RATE MODE WITH 2000MCG IN THE INTERNAL TUBING AND CATHETER AND 500MCG IN THE RESERVOIR. THE PUMP WAS PROGRAMMED TO THE MINIMUM RATE UNTIL A SYSTEM CONTENTS REMOVAL PROCEDURE COULD BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 29 YR Other EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863720,| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N269371001| CATHETER: MODEL 8709, LOT# N095848007| LOT # NGP029479N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: