BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2182323 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05313
    Event Type
    Injury
    Date Received
    July 11, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PATIENT HAD COGNITIVE DEFICIT AFTER PUMP REFILL; PUMP WAS EXPLANTED AND REPLACED. IT WAS UNKNOWN IF THE EVENT WAS ATTRIBUTED TO THE DEVICE OR ITS COMPONENTS. THE SURGICAL OUTCOME WAS "GOOD" AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY. DRUG DELIVERED VIA THE PUMP WAS FENTANYL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD EXPERIENCED A CHANGE IN THERAPY EFFECT SINCE THE LAST TWO REFILLS. A COUPLE HOURS AFTER THE REFILL PATIENT HAD TROUBLE SPEAKING AND HAD NEUROLOGICAL DEFICIT. PT'S HUSBAND STATED IT WORE OFF OVER NIGHT. THE SAME INCIDENT OCCURRED AT THE NEXT REFILL BUT LASTED FOR 3-4 DAYS. HCP WAS NOT ABLE TO IDENTIFY THE PROBLEM. ACCORDING TO THE HCP "PT HAD BEEN RECEIVING THE SAME DRUGS AND CONCENTRATION BUT MIGHT HAVE HAD A DOSE INCREASE IN SEPTEMBER." ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N123193027