BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3082534 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07007
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME IN FOR A PUMP REFILL (B)(6) 2013 AND WAS HAVING IN ISSUE WITH HIS PTM (PERSONAL THERAPY MANAGER). HE USED THE PTM JUST BEFORE THEY REFILLED THE PUMP AND THE TONE ESCALATED LIKE IT GAVE HIM HIS BOLUS AND THERE WAS A CHECK, BUT THE SCREEN WAS CONSTANTLY READING (B)(6) 2013 AND NOT CHANGING AT ALL; IT HAD BEEN THIS WAY SINCE THE LAST REFILL. AFTER REFILLING AND UPDATING THE PUMP, IT WAS STILL READING THE JANUARY DATE. THE PTM WAS DECOUPLED AND RECOUPLED TO THE PUMP, BUT THE PATIENT WASN'T PRESENT TO TEST IF THAT HAD WORKED. THE PUMP WAS DELIVERING MORPHINE, CLONIDINE, AND BACLOFEN. THERE WERE NO VOLUME DISCREPANCIES WITH THE PUMP; IT SAID 10.2 WAS EXPECTED AND 10.2 WAS WITHDRAWN. THE PATIENT DIDN'T USE THE PTM ALL THE TIME, BUT DID YOU USE IT TO SCHEDULE HIS REFILL VISITS, SO THE PATIENT WAS FRUSTRATED THAT THE REFILL DATE WASN'T CHANGING. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183798 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1