BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2990541 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03358
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6) PRODUCT TYPE CATHETER PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND THAT THE MOTOR WAS INCORRECTLY POSITIONED. THIS WAS NOTED TO BE A MANUFACTURING ISSUE. NOTHING SIGNI FICANT WAS FOUND THAT MAY HAVE CAUSED THE MOTOR STALL. DURING ANALYSIS, THE MOTOR WAS FOUND TO BE NOT CORRECTLY SEATED WHEN IT WAS WELDED INTO PLACE. THERE WAS AN OBSERVED GAP BETWEEN THE PAD ON THE TOP BRIDGE OF THE MOTOR AND THE PUMP HEAD¿S TOP PLATE. EVEN THOUGH THIS GAP WAS APPARENT IT DID NOT SEEM TO AFFECT THE TURNING OF THE PUMP HEAD. IT WAS NOTED THE MESHING OF THE TEETH OF GEAR WHEEL 3 WITH THE TEETH OF THE PUMP HEAD GEAR WAS SUFFICIENT TO TRANSFER THE CORRECT AMOUNT OF TORQUE. NO DEGRADATION WAS SEEN ON THE TEETH OF GEAR WHEEL 3.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND GEAR TRAIN ANOMALIES WITH THE MOTOR, CORROSION AND/OR WEAR AND/OR LUBRICATION ALONG WITH A STALL DUE TO SHAFT-BEARING. ANALYSIS ALSO FOUND AS PREVIOUSLY REPORTED THE MOTOR TO BE INCORRECTLY POSITIONED DUE TO A MANUFACTURING ISSUE. DURING ANALYSIS, RESIDUE WAS FOUND ON THE UPPER AND LOWER SHAFTS OF THE ROTOR MAGNET. SHAFT WEAR WAS ALSO FOUND ON THE LOWER SHAFT OF THE ROTOR MAGNET. RESIDUE WAS ALSO FOUND ON THE JEWEL WHERE THE LOWER SHAFT OF THE ROTOR MAGNET INSERTS INTO THE TOP BOTTOM ASSEMBLY. DURING ANALYSIS, IT WAS NOTICED THE MOTOR WAS NOT CORRECTLY SEATED WHEN IT WAS WELDED INTO PLACE. THERE WAS AN OBSERVED GAP BETWEEN THE PAD ON THE TOP BRIDGE OF THE MOTOR AND THE PUMPHEAD¿S TOP PLATE. EVEN THOUGH THE GAP WAS APPARENT IT DID NOT SEEM TO AFFECT THE TURNING OF THE PUMPHEAD. THE MESHING OF THE TEETH OF GEAR WHEEL THREE WITH THE TEETH OF THE PUMPHEAD GEAR WAS SUFFICIENT TO TRANSFER THE CORRECT AMOUNT OF TORQUE. NO DEGRADATION WAS SEEN ON THE TEETH OF GEAR WHEEL THREE. (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

    ADDITIONAL INFORMATION RECEIVED REPORTED A STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE WAS SEEN ON (B)(6) 2013. EVENTUAL RECOVERY OF THE MOTOR STALL OCCURRED ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS EXPLANTED. THE PUMP LOGS INDICATED THAT A THIRD MOTOR STALL HAD OCCURRED ON (B)(6) 2013 WHICH WAS FOLLOWED BY A MOTOR STALL RECOVERY TWENTY FIVE MINUTES LATER. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ON (B)(4) 2013, TELEMETRY LOGS CONFIRMED THAT TWO MOTOR STALLS HAD OCCURRED. THE FIRST STALL RECOVERED WITHIN THIRTY MINUTES, AND THE SECOND STALL RECOVERED WITHIN FIVE HOURS. THE PATIENT HAD NOT HAD ANY MRI'S. NO PATIENT SYMPTOMS WERE REPORTED, AND IT WAS NOTED THAT THE PATIENT "MIGHT CHOOSE TO NOT REPLACE THEIR PUMP AT THIS TIME". THE MEDICATION USED WITHIN THE SYSTEM WAS GABLOFEN 1000MCG/ML. THE PATIENT WAS NOTED TO HAVE RECOVERED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PUMP HAD FAILED AFTER A SHORT PERIOD OF TIME. THE PUMP HAD NOT YET BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92898 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention