BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3832001 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09606
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALIES, INCLUDING CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHAFT BEARING. THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES SEEN IN THE LOGS. THE PUMP WAS RECEIVED FOR ANALYSIS WITH A HARD MOTOR STALL THAT NEVER RECOVERED. DURING ANALYSIS, SIGNIFICANT RESIDUE AND SHAFT WEAR ON THE LOWER SHAFT OF GEAR 2 WAS FOUND. THERE WAS ALSO SOME RESIDUE FOUND ON THE JEWEL WHERE THE LOWER SHAFT OF GEAR 2 INSERTED INTO THE BOTTOM BRIDGE ASSEMBLY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED AND THE STALL RECOVERED AFTER MORE THAN 2 HOURS. THE PATIENT EXPERIENCED SEIZURES AND FELT STOMACH WOOZINESS. HOSPITALIZATION AND A PUMP REPLACEMENT WERE REQUIRED. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS INDICATED TO BE ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND DILAUDID.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A WITHDRAWAL OF NARCOTICS, INCREASED PAIN AND NAUSEA. THE PUMP STALLED FOR GREATER THAN OR EQUAL TO 24 HOURS. THERE WAS ONE MOTOR STALL NOTED IN THE EVENT LOGS. THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS LATER REPORTED THAT THE MOTOR STALL OCCURRED ON 2014 (B)(6) AND RECOVERED ON 2014 (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE STALL WAS NOT IDENTIFIED. ON (B)(6) 2014, BEFORE REPLACEMENT THE PATIENT HEARD AN ALARM. THE PATIENT WAS THEN INSTRUCTED BY THE OFFICE TO COME IN TO SEE THE HEALTH CARE PROVIDER (HCP) BUT THE PATIENT DIDN'T WANT TO COME IN UNTIL THE FOLLOWING (B)(6) FOR A NORMAL REFILL OF THE PUMP. THE PATIENT HAD WITHDRAWAL SYMPTOMS AND A SEIZURE IN THE EMERGENCY ROOM ON (B)(6) 2014. SHE WAS THEN TRANSFERRED TO HER MANAGING PUMP HCP WHERE THE REPLACEMENT OCCURRED. IN TERMS OF IF THE SEIZURE WAS RELATED TO THE MOTOR STALL AND AFTER EFFECTS, NARCOTIC WITHDRAWAL, IT WAS REPORTED THE RELATION WAS UNKNOWN BUT NOTED THAT BOTH HAPPENED AT THE SAME TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310509 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R