BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181806 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10688
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J0058128R, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND THAT THE MOTOR HAD BEEN INCORRECTLY POSITIONED AND THERE WAS SHORTING ACROSS AN INSULATOR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING EVERY HOUR. UPON INTERROGATION, IT WAS SEEN THAT THE PUMP WAS IN SAFE-STATE AND LOW-BATTERY RESET HAD OCCURRED. THE FIRST RESET HAD OCCURRED AT 11:36PM OF THE PRIOR DAY, BUT SEVERAL HAD OCCURRED UP UNTIL 5:10AM ON THE DAY OF REPORT. AT THE TIME OR REPORT, THE PATIENT APPEARED TO BE GOING THROUGH TYPICAL WITHDRAWAL SYMPTOMS FOR NARCOTICS. SYMPTOMS HAD STARTED EARLIER THAT MORNING AND INCLUDED PAIN, SWEATS, AND FEELING HOT AND COLD. LATER THAT DAY, IT WAS REPORTED THAT THE PUMP EXPERIENCED PREMATURE BATTER DEPLETION. THE PATIENT WAS PLACED ON ORAL MEDICATIONS, THE PUMP WAS SET TO MINIMUM RATE, AND THE PUMP REPLACEMENT WAS SCHEDULED. ADDITIONAL UNDERDOSE SYMPTOMS WERE REPORTED TO INCLUDE HEADACHES AND LESS THAN 50% THERAPY RELIEF. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER INFUMORPH AND CLONIDINE. SIX DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD RECOVERED WITHOUT SEQUELA AND THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD TO HAVE EMERGENCY SURGERY DUE TO THE PUMP ¿MALFUNCTIONING¿. IT WAS REPORTED ON (B)(6) THE PATIENT WAS SUPPOSED TO HAVE HAD A FOOT OPERATION BUT IT WAS CANCELLED. THE PATIENT HAD BEEN FEELING ¿WEIRD¿ AND HEARD THE AS PREVIOUSLY REPORTED CHIRPING NOISE EVERY HOUR. AT FIRST THE PATIENT THOUGHT THE CHIRPING NOISE WAS SOMETHING HOUSEHOLD BUT THEN HE HAPPENED TO LOOK DOWN AT THE PUMP RIGHT WHEN IT BEEPED. THE PATIENT THEN CALLED HIS HEALTH CARE PROVIDER (HCP) BUT HADN¿T HEARD BACK FROM HIM SO HE STARTED DRIVING TO THE HCP. BY THE TIME THE PATIENT STARTED DRIVING THERE, HE WAS GOING THROUGH ¿TERRIBLE¿ WITHDRAWALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283572 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention