BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090739 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17069
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 26, 2014
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (SN (B)(4)) FOUND THE PUMP MOTOR STALL WAS DUE TO A COIL SHORTING TO THE CASE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS REPLACED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL ((B)(6) 2014 18:11) AND CRITICAL ALARM. A MOTOR STALL WAS RECORDED ((B)(6) 2014 14:44). A REPLACEMENT HAD BEEN SCHEDULED AT THE DATE OF INITIAL REPORT, BUT FURTHER INFORMATION REPORTED THE REPLACEMENT WAS CANCELED DUE TO PUMP RECOVERY. THE PATIENT HAD INCREASED SPASTICITY AND LATER REPORTED, THE PATIENT'S HEALTH WAS "GOOD RIGHT NOW". THE PUMP WAS USED TO DELIVER LIORESAL (BACLOFEN), AND THE PATIENT HAD TAKEN ORAL LIORESAL WHILE THE PUMP WAS STALLED.

    Description of Event or Problem · 1

    IT WAS THE PUMP WAS ALARMING WITH A CRITICAL ALARM. THE PUMP HAD STALLED, AGAIN. LOGS SHOWED AN ALTERNATION BETWEEN MOTOR STALLED AND RESTARTED. THE PUMP WOULD BE EXPLANTED "NEXT WEEK" AS OF (B)(6) 2014 WHEN "THE PATIENT WILL BE CURED OF A RESPIRATORY INFECTION".

    Description of Event or Problem · 1

    PUMP LOGS WERE RECEIVED. A "STOPPED PUMP DURATION MAY EXCEED 'TUBE SET'" ERROR CODE WAS OBSERVED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569500 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Required Intervention