BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1994349 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00389
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ABLE TO ASPIRATE THE PUMP, BUT NOT ABLE TO REFILL IT. THE REFILL TUBING WAS PATENT. THERE WAS NO DEPTH ISSUE. THE PUMP DID NOT MOVE AROUND IN THE POCKET. THEY FELT THE SILICONE RUBBER SEPTUM. THE NEEDLE WAS PATENT. THE LOCKED RESERVOIR VALVE PROCEDURE WAS REVIEWED AND THEY WERE STILL UNABLE TO FILL THE PUMP. AN X-RAY WAS OBTAINED AND IT APPEARED THAT ONE SIDE OF THE BELLOWS WAS LESS CONTACTED THAN THE OTHER. THE PHYSICIAN ATTEMPTED TO FILL THE PUMP WITH SALINE SEVERAL TIMES, AND IT STILL WOULDN'T ALLOW IT, UNTIL, FINALLY HE WAS ABLE TO INJECT AND ASPIRATE. HE THEN WENT TO INJECT THE MEDICATION AND WAS ONLY ABLE TO INJECT 15 CC. THE PATIENT HAD NO THERAPY OR MEDICAL PROBLEM RELATED TO THE EVENT. THE PHYSICIAN SCHEDULED THE PATIENT FOR A PUMP REPLACEMENT ON (B)(6), BUT THE PATIENT CANCELLED DUE TO THE (B)(6). SHE HAD NOT BEEN RESCHEDULED AND IT WAS UNKNOWN HOW SHE WAS PRESENTLY DOING. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N252894003| PROGRAMMER: MODEL 8835, LOT# NPG017264N