BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6011855 · Received October 7, 2016

    Report

    Report Number
    3004209178-2016-21335
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011, Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. 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

    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. THE PUMP AND PARTIAL CATHETER WERE RETURNED TO THE MANUFACTURER. ANALYSIS OF THE PUMP ON 2016-OCT-25 REVEALED HIGH BATTERY RESISTANCE. AS PER THE PUMP'S LOG A RESET, LOW BATTERY RESET, AND SAFE STATE HAD OCCURRED ON (B)(6) 2016 AT 06:59. ALSO PER THE LOGS THE FOLLOWING MEDICATIONS WERE BEING ADMINISTERED AS OF (B)(6) 2016: HYDROMORPHONE WITH CONCENTRATION 4.4 MG/ML AT A DOSE RATE OF 1.1091 MG/DAY AND BUPIVACAINE WITH CONCENTRATION 8.0 MG/ML AT A DOSE RATE OF 2.0165 MG/DAY. ANALYSIS OF THE CATHETER ON 2016-OCT-25 REVEALED CORING/TEARS/CUTS IN SEAL REGARDING THE SUTURELESS CATHETER CONNECTOR; LEAKING WAS SEEN (MET LEAK CRITERIAL PER NDHF1162-113599). (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

    CORRECTED INFORMATION: SEX, DATE OF BIRTH, NO EVAL EXPLAIN CODE. 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) REGARDING A PATIENT WITH AN IMPLANTED INFUSION PUMP CONTAINING HYDROMORPHONE (4.4MG/ML DISPENSING 1.1091MG PER DAY) AND BUPIVACAINE (8MG/ML DISPENSING 2.0165MG PER DAY). INDICATIONS FOR USE INCLUDED LUMBAR RADICULOPATHY AND SPINAL PAIN. ON (B)(6) 2016, THE HCP REPORTED THAT THE PATIENT'S PUMP WAS ALARMING AND WAS IN MINIMUM RATE MODE. PUMP LOGS INDICATED THAT LOW BATTERY RESET AND SAFE STATE OCCURRED ON (B)(6) 2016. THE PATIENT'S SYMPTOMS INCLUDED INCREASED PAIN, "FEELING LIKE CRAP," AND DIARRHEA. IT WAS LATER REPORTED BY THE PATIENT VIA A MANUFACTURER REPRESENTATIVE THAT THEY WERE ABLE TO RESTART THE PUMP ON (B)(6) 2016. WHEN THE PUMP WAS READ ON (B)(6) 2016, IT APPEARED TO STILL BE RUNNING. THE PUMP WAS THEN EXPLANTED ON (B)(6) 2016 AND RETURNED FOR ANALYSIS. THE ISSUE WAS STATED TO BE RESOLVED AND PATIENT STATUS WAS ALIVE - NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE PUMP WAS NOTED AS HAVING BEEN REPLACED BECAUSE OF A STALL AND THEY WANTED TO SYNC THE NEW PUMP TO THE PATIENT'S PERSONAL THERAPY MANGER (PTM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663377 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention