BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5529722 · Received March 28, 2016

    Report

    Report Number
    3004209178-2016-05486
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 6, 2016
    Report Date
    March 28, 2016
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A (B)(6), MALE PATIENT WHO WAS RECEIVING LIORESAL 300MCG/ML AT 98.87 MCG/DAY AND DILAUDID 7MG/ML AT 2.3 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND POST LUMBAR LAMINECTOMY SYNDROME. THE PATIENT'S MEDICAL HISTORY WAS REPORTED AS "NONE" AND THEIR CONCOMITANT MEDICATIONS WERE UNKNOWN. ON (B)(6) 2016, THE PATIENT'S PUMP STARTED TO ALARM. THE PATIENT EXPERIENCED AN INCREASE IN PAIN AND SPASTICITY SINCE THEN. ON (B)(6) 2016, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER), BUT WAS QUICKLY DISCHARGED AFTER SEEING THE ATTENDING ER PHYSICIAN. THE COMPANY REPRESENTATIVE WENT TO SEE THE PATIENT TO INTERROGATE HIS PUMP AND THE LOGS CONFIRMED A MOTOR STALL ON (B)(6) 2016. AT THAT TIME, THE PATIENT WAS "DOING RATHER WELL, OUTSIDE THE INCREASED PAIN." HIS SPASTICITY WAS UNDER CONTROL AS HE WAS ABLE TO TAKE SOME ORAL BACLOFEN AS A SUPPLEMENT. THE PATIENT HAD NOT BEEN EXPOSED TO ANY ELECTROMAGNETIC INTERFERENCE (EMI) NOR HAD A RECENT MAGNETIC RESONANCE IMAGING (MRI). THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. NO DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED AND THERE WAS "NO IMMEDIATE REPORTS OF NERVE TIGONS PERFORMED." AS OF (B)(6) 2016, THE EVENT HAD NOT RESOLVED. IT WAS LATER REPORTED, A STOPPED PUMP PERIOD MAY EXCEED TUBE SET OCCURRED ON (B)(6) 2016 AND THE MOTOR STALL RECOVERED ON (B)(6) 2016. THE PATIENT'S STATUS WAS REPORTED AS "ALIVE - NO INJURY." SURGICAL INTERVENTION DID NOT OCCUR AND IT WAS UNKNOWN IF IT WAS PLANNED. THE PATIENT'S MANAGING PHYSICIAN WAS OUT OF TOWN, SO THE PLAN GOING FORWARD WAS PUT ON HOLD UNTIL THEY RETURNED. THE DECISION TO REPLACE THE PUMP WAS FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186074 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR