BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3881405 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11762
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    October 31, 2016
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED RESERVOIR ACCESS ISSUES DUE TO RESIDUE IN THE FLUID PATH. DURING ANALYSIS, THE ANALYST WAS UNABLE TO EXTRACT ANY FLUID FROM THE PUMP RESERVOIR AND THE CATHETER ACCESS PORT WAS NO LONG PATENT. AN EXTREME AMOUNT OF THICK WHITE FOREIGN MATERIAL WAS FOUND IN THE FLUID PATHWAY AND IN THE RESERVOIR BELLOWS. UPON DEVICE INTERROGATION, IT WAS INDICATED THAT THE PUMP CONTAINED VANCOMYCIN.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, AS OF 2014-05-07, THE EVENT STATUS WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2014, A POSSIBLE OVERDOSE OCCURRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL OF SUSPECTED ASPIRATION PNEUMONIA, RESPIRATORY FAILURE AND ACUTE RENAL FAILURE. THE HEALTHCARE PROVIDER (HCP) WAS NOTIFIED BY THE PATIENT¿S FAMILY THAT THE PATIENT WAS EXPERIENCING ALTERED MENTAL STATUS AND SEDATION RELATED TO TOO MUCH OPIOID. IT WAS NOTED THAT THE PATIENT WAS CURRENTLY ALSO BEGIN TREATED FOR CONGESTIVE HEART FAILURE AND ATRIAL FIBRILLATION. THERAPY WAS SUSPENDED ON (B)(6) 2014 AND WAS RESUMED AND REPROGRAMMED THE FOLLOWING DAY. AS OF THE SAME DATE, THE EVENT OUTCOME WAS INDICATED TO BE ONGOING. THE EVENT SEVERITY WAS INDICATED TO BE MODERATE, PRODUCING SOME IMPAIRMENT OF FUNCTIONING BUT NOT HAZARDOUS TO HEALTH. IT WAS LATER REPORTED THAT THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PROGRAMMING DATE FROM THE MOST RECENT REFILL PRIOR TO THE EVENT WAS (B)(6) 2014. EXAMINATION ON (B)(6) 2014 REVEALED AN ALTERED MENTAL STATUS AND SEDATION, WHICH WAS INDICATED TO BE RELATED TO THE INTRATHECAL HYDROMORPHONE. IT WAS LATER REPORTED THAT THE HCP ORDERED A MAGNET OVER THE PUMP ON (B)(6) 2014. (B)(6) 2014 (RP/REP): IT WAS LATER REPORTED THAT PUMP AND CATHETER WERE EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED AN UPDATED DATE OF EVENT TO (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT SERIOUSNESS WAS LISTED AS; SERIOUS DETERIORATION IN THE HEALTH OF THE PATIENT AND RESULTED IN PROLONGED OR IN-PATIENT HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357988 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R