BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032443 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02300
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 0

    THE DEVICE SYSTEM WAS DELIVERING HYDROMORPHONE 16.3 MG/ML AT 0.106 MG/DAY AND CLONIDINE 187.5 MCG/ML AT 1.21 MCG/DAY.

    Description of Event or Problem · 0

    AS OF (B)(6) 2011, THE PATIENT WAS "FINE" AND WAS RECEIVING "GOOD EFFECT" FROM THE REPLACEMENT PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SEVERE UNDERDOSE SYMPTOMS. WHEN THE PT ARRIVED AT THE HOSP TO SEE WHAT HAD HAPPENED, THE PROGRAMMER SHOWED THAT THE PUMP HAD SET ITSELF INTO SAFE STATE MODE WITH A MINIMUM RATE. THE ERI (ELECTIVE REPLACEMENT INDICATOR) SHOWED 12 MONTHS AND THERE WERE NO ALARM INDICATING THAT SOMETHING WAS WRONG. THE PUMP LOGS SHOWED THAT THE PUMP HAD SET ITSELF TO SAFE STATE DUE TO LOW "BATTERY-RESET" ON (B)(6) 2011. THE PUMP WAS REPLACED. THE PT OUTCOME WAS STATED AS "UNK." THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE HYDROMORPHONE AND CLONIDINE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586567 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization| R UNK.