BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872621 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07877
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT'S ELECTIVE REPLACEMENT INDICATOR (ERI) DROPPED SIGNIFICANTLY TO 24 MONTHS, TWO MONTHS POST-IMPLANT. THE PT THERAPY MANAGER (PTM) READ "UNSUCCESSFUL ACTIVATIONS" AND "500!". THE PT STATED THERE WAS NO WAY HE REQUESTED A BOLUS 500 TIMES. LATER THE PT REPORTED HE RECEIVED A 0616 ERROR CODE ON THE PTM. A MINUTE AFTER THE PT RECEIVED THIS CODE THE PT TRIED TO GIVE THEMSELVES A BOLUS AND THE LOCK OUT INTERVAL STATED 3 HOURS AND 16 MINUTES. THE PT STATED HE WAS REASONABLY CERTAIN THE PUMP MALFUNCTIONED. THE HCP TOOK AWAY SIMPLE CONTINUOUS DOSING AND WAS ON 100% BOLUSES. IT WAS SUBSEQUENTLY REPORTED THE PT WILL REVIEW THE PUMP LOGS WITH THE COMPANY REP AT THE NEXT REFILL. THE PT WAS CURRENTLY PROGRAMMED TO FLEX DOSING AND WAS NOT USING THE PTM. THE PT STATUS WAS NOT NOTED AT THE TIME OF THIS REPORT. THE PUMP CONTAINED BUPIVACAINE, CLONIDINE AND SUFENTANIL; THE DOSAGE AND CONCENTRATION WERE UNK. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8578, LOT# N252824015| CATHETER: MODEL 8709, LOT# J53385R08| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NGP017778N| IMPLANTED:| EXPLANTED: