BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962354 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02671
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN: PRODUCT ID 8835, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY COMMUNICATING WITH AND COULD NOT READ THIS PUMP. THE PATIENT ALSO REPORTED THAT THE PERSONAL THERAPY MANAGER (PTM) DID NOT COMMUNICATE WITH THE PUMP. TROUBLESHOOTING INVOLVING ELECTROMAGNETIC INFERENCE (EMI) AND BATTERIES WERE ATTEMPTED WITHOUT SUCCESS. ULTIMATELY, A REVISION OCCURRED AS THE PATIENT WAS VERY THIN AND THE PUMP WAS MOVED DEEPER. AFTER THE REPOSITIONING THE PUMP WAS THEN ABLE TO BE READ. THERE WERE NO PATIENT SYMPTOMS OR THERAPY ISSUES REPORTED. THIS PUMP SYSTEM WAS USED TO DELIVER FENTANYL AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65884 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention