BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800119 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08725
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # J10925R18, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (B)(4) REVEALED A PUMP MOTOR GEAR TRAIN ANOMALY INVOLVING A STALL DUE TO SHAFT-BEARING AS WELL AS A PUMP MOTOR GEAR TRAIN ANOMALY INVOLVING CORROSION AND/OR WEAR AND/OR LUBRICATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS CONFIRMED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. IT WAS NOTED THAT MULTIPLE MOTOR STALLS AND MOTOR STALL RECOVERY MESSAGES WERE NOTED IN THE PUMP LOGS STARTING ON (B)(6) 2014. IT WAS FURTHER NOTED THAT THERE WERE TWO MOTOR STALLS ON (B)(6) 2014 WITH A RECOVER OCCURRING AT 16:00 AND THE FINAL STALL AT 23:08 WITH NO RECOVERY. THE REPORTER STATED THERE WAS A ¿STOP PUMP PERIOD MAY EXCEED TUBE SET¿ MESSAGE IN THE LOGS ON (B)(6) 2014 AT 23:08. IT WAS NOTED THE PATIENT DID NOT HEAR THE PUMP ALARM AND THE CURRENT RESERVOIR VOLUME WAS 31.3 ML. IT WAS FURTHER NOTED THE PATIENT WAS EXPERIENCING AN INCREASE IN PAIN LEVEL. THE REPORTER STATED THE PATIENT HAD BEEN IN SEVERE PAIN FOR SEVERAL DAYS NOW. THE REPORTER FURTHER STATED THEY PLANNED TO REPLACE THE PUMP TOMORROW. IT WAS NOTED THE ELECTIVE REPLACEMENT INDICATOR OF THE PUMP READ LESS THAN ONE MONTH. THE PUMP CONTAINED DILAUDID (HYDROMORPHONE). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING INCREASED PAIN. IT WAS NOTED THE PATIENT WAS GIVEN A NEW PUMP AND THEIR SYMPTOMS RETURNED TO NORMAL. THE REPORTER STATED THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) WAS AWARE THAT THE PUMP WAS SHOWING ERI AND THEY WERE TRYING TO GET AS MUCH LIFE OUT OF IT AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278788 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention