BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5939696 · Received September 9, 2016

    Report

    Report Number
    3004209178-2016-18618
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 10, 2016
    Report Date
    October 5, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP ON (B)(6) 2016 REVEALED A MOTOR GEAR TRAIN ANOMALY REGARDING CORROSION AND/OR WEAR AND/OR LUBRICATION; THE STALL WAS DUE TO THE SHAFT BEARING. REGARDING ANALYSIS, THE LOGS REVEALED MULTIPLE MOTOR STALLS AND MOTOR STALL RECOVERIES HAVING OCCURRED FROM (B)(6) 2016. ANALYSIS OF THE CATHETER ON (B)(6) 2016 REVEALED WHAT APPEARED TO BE A MATERIAL FAILURE REGARDING THE SUTURELESS CATHETER CONNECTOR. REGARDING ANALYSIS OF THE CATHETER, PHOTOS SHOWED DAMAGE ON ONE OF THE RETAINING RING FINGERS; SHOWED A CRACK IN THE RETRAINING RING REGARDING THE SUTURELESS CATHETER CONNECTOR. (B)(4). 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

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2016, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML LIORESAL AT 1800.4 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND POST SPINAL CORD INJURY. IT WAS REPORTED THAT THERE WAS A PUMP ALARM AND THE PATIENT HAD WITHDRAWAL SYMPTOMS. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS WERE NOTED TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN DID A ROTOR STUDY ON (B)(6) 2016 AND STATED THE ROTOR DID NOT MOVE. A MOTOR STALL OCCURRED ON (B)(6) 2016 AT 15:02 WITH A RECOVERY ON (B)(6) 2016 AT 01:19; ON (B)(6) 2016 AT 02:53 WITH A RECOVERY ON (B)(6) 2016 AT 10:58; ON (B)(6) 2016 AT 06:03 WITH A RECOVER ON (B)(6) 2016 AT 14:58; ON (B)(6) 2016 AT 07:44 WITH A RECOVERY ON (B)(6) 2016 AT 16:13; ON (B)(6) 2016 AT 06:05 WITH A RECOVERY ON (B)(6) 2016 AT 19:14; ON (B)(6) 2016 AT 19:18 WITH A RECOVERY ON (B)(6) 2016 AT 10:39; AND ON (B)(6) 2016 AT 20:08 WITH NO RECOVERY. THE PUMP WAS EXPLANTED AND REPLACED. AT THE TIME OF PUMP REPLACEMENT, THEY WERE UNABLE TO ASPIRATE THE CATHETER, SO IT WAS ALSO REPLACED. THE ISSUE WAS NOTED TO BE RESOLVED AND THE PATIENT HAD RECOVERED WITHOUT SEQUELAE. THE PATIENT WAS NOTED TO BE "ALIVE - NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591697 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention