BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3033806 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04580
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALIES. HOWEVER THERE WAS MOTOR STALL RECOVERY IN THE LOGS. WHILE SOME RESIDUE SEEN ON GEAR THREE'S O-RING LOCATED ON THE TOP BRIDGE OF THE PUMP, PER LAB TESTING THE RESIDUES WERE NOT ENOUGH TO CAUSE A MOTOR STALL AND NOTHING SIGNIFICANT WAS FOUND ON FURTHER ANALYSIS THAT MAY HAVE CAUSED THIS MOTOR STALL. RETURNED FOR ANALYSIS WAS A PARTIAL CATHETER THAT REVEALED NO SIGNIFICANT ANOMALIES AS WELL.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED PAIN AT THE PUMP SITE AND NAUSEA. TWENTY MILLILITERS OF PURULENT APPEARING FLUID WAS ASPIRATED RELATED TO THE PUMP POCKET INFECTION. THE PATIENT WAS ADMINISTERED VANCOMYCIN AND ZOSYN. THE ENTIRE SYSTEM WAS EXPLANTED WHICH REQUIRED IN-PATIENT OR PROLONGED HOSPITAL STAY. THE DEVICE SYSTEM DELIVERED DILAUDID, BUPIVACAINE, BACLOFEN AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136488 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| R