BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4102716 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17394
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD DISCOMFORT AT THEIR PUMP SITE. THE PATIENT HAD AN UNSCHEDULED CLINIC/OFFICE VISIT AND WAS EXAMINES. THE PUMP WAS DETERMINED TO BE "HYPERMOBILE WITHIN THE POCKET" AND WAS EASILY MOVED AND COULD EASILY "INVERT OF FLIP". A PUMP MIGRATION WAS ALSO NOTED. THE EVENT WAS LISTED AS ONGOING. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. OUTCOME OF THE EVENT WAS NOT REPORTED AND A SUPPLEMENTAL REPORT WOULD BE SENT IF THE INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT ALTHOUGH THE EVENT HAD RESULTED IN AN UNSCHEDULED CLINIC OR OFFICE VISIT, IT RESOLVED WITHOUT SEQUELA ON (B)(6) 2015. NO SPECIFIC REASON FOR THE PUMP BEING HYPER-MOBILE IN THE POCKET WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERAPY WAS SUSPENDED AS A RESULT OF THE EVENT ON (B)(6)2015. THE MOST RECENT DATE THE EVENT WAS CONFIRMED ON-GOING/UNRESOLVED WAS (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584931 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR