BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2250674 · Received September 12, 2011

    Report

    Report Number
    3004209178-2011-07722
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    July 31, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S PUMP HAD MULTIPLE MOTOR STALLS THAT WERE CONFIRMED; THERE WERE 26 MOTOR STALLS BETWEEN (B)(6) 2011 AND (B)(6) 2011. PER THE REPORTER, THE PT WAS "UPSET RIGHT NOW." THE NURSE HAD DIFFICULTIES ASSESSING THE PT HAD STATED THAT THE PT "MAY BE HAVING WITHDRAWAL SYMPTOMS." TROUBLESHOOTING OPTIONS WERE CONSIDERED INCLUDING, REPLACING THE PUMP IF THE PT WAS MEDICALLY STABLE AND PROGRAMMING THE PUMP INTO MINIMUM RATE MODE IF PT WAS ALSO TAKING SUPPLEMENTAL ORAL MEDICATIONS. THE PUMP CONTAINED BACLOFEN AT A CONCENTRATION OF 2000 MCG/DL. ADDITIONAL INFORMATION 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 LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female ACCESSORY: MODEL 8590-1, LOT# N250542| CATHETER: MODEL 8711, LOT# N239502005| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N250542| CATHETER: MODEL 8711, LOT# N239502005| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: