BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5350357 · Received January 7, 2016

    Report

    Report Number
    3004209178-2016-00206
    Event Type
    Injury
    Date Received
    January 7, 2016
    Date of Event
    November 17, 2015
    Report Date
    January 4, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER RECEIVING DILAUDID 5MG/ML AT 0.3265 MG/DAY AND THEN DILAUDID 5MG/ML AT 0.2403 MG/DAY VIA AN IMPLANTABLE PUMP. THE PATIENT WAS ALSO PRESCRIBED ORAL HYDROCODONE AND XANAX IN (B)(6) 2015. THE INDICATION FOR USE WAS SPINAL PAIN. THE PATIENT REPORTED THEY THOUGHT THERE WAS AN ISSUE WITH THE MEDICATION THAT WAS CURRENTLY IN THE PUMP. THE PATIENT STATED THEY SPENT 35 DAYS IN HELL STATING THEY PULLED OUT MEDICATION AND PUT IN NEW MEDICATION, LOWERED THE MEDICATION AFTER TWO WEEKS AND THE PATIENT'S PROBLEMS WERE STILL HAPPENING, THE PATIENT STATED THEY STARTED HAVING OVERDOSE ISSUES AND SIDE EFFECTS FROM THE MEDICATION IN (B)(6) 20105. THE PATIENT WENT TO ER (EMERGENCY ROOM) 5-6 TIMES AND COULDN'T FIGURE OUT WHY THE PATIENT WAS GETTING SO SICK . THE HEALTHCARE PROVIDER TOLD THE PATIENT HE HAD ALL THE SIGNS OF SYMPTOMS OF A DRUG OVERDOSE AND THEY LOWERED THE MEDICATION IN THE PUMP. THE PATIENT SAW THE PHYSICIAN'S ASSISTANT IN THEIR HEALTHCARE PROVIDER'S OFFICE AND THE PHYSICIAN'S ASSISTANT CHANGED THE MEDICATION IN THE PUMP IN (B)(6) 2015. THE NURSE FROM THE OFFICE LOWERED THE DOSAGE OF THE PUMP MEDICATION (B)(6) 2015. THE PATIENT STATED THEY CAN'T REACH HIS PHYSICIAN'S OFFICE WOULD LIKE TO REACH THEM REGARDING THEIR CONTINUED ISSUES. THE PATIENT WAS SEEKING A NEW PHYSICIAN. DIAGNOSTICS RELATED TO THE PATIENT'S SYMPTOMS, CLARIFICATION OF THE "OVERDOSE" L IKE SYMPTOMS AND OUTCOME NOT REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8901 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Other