BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3173834 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10498
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT¿S INCREASED PAIN WAS DUE TO INCREASED ACTIVITY PER THE HEALTHCARE PROVIDER (HCP). THE HCP STATED THAT THERE WAS NO PROBLEM WITH THE DEVICE SYSTEM. THE HCP INITIALLY INDICATED THAT PATIENT DEATH OCCURRED; HOWEVER, THIS SEEMED TO BE AN ERROR AS THE HCP ALSO LATER STATED THAT THE PATIENT HAD NO INJURY. CONFLICTING INFORMATION WAS PROVIDED THAT THE DEVICE SYSTEM DELIVERED DILAUDID AND BUPIVACAINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TO HAVE AN MRI OF THE LUMBAR SPINE DUE TO SEVERE BACK PAIN. IT WAS LATER REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AND THOUGHT THAT SOMEONE MAY HAVE ¿TURNED HIS PROGRAMMER OFF REMOTELY¿. THE PATIENT HAD THE MRI EARLIER THAT DAY. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND THE PUMP WAS NOT ALARMING. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 FOR CHRONIC PAIN. THE PATIENT¿S DOCTOR HAD WRITTEN AN ORDER THE DAY PRIOR TO THE REPORT TO HAVE THE PUMP INTERROGATED DUE TO THE RECENT MRI. THE DOCTOR STATED THAT THERE WAS A ¿FAIL-SAFE SWITCH¿ ON THE PUMP AND WANTED TO VERIFY THAT THE PUMP WAS STILL WORKING AS THE PATIENT WAS NOT FEELING THE MEDICATION AND NOT RECEIVING THE RELIEF THAT HE WAS PRIOR TO THE MRI. CONFLICTING INFORMATION WAS PROVIDED AS THE CALLER BELIEVED THE DEVICE WAS USED TO DELIVER DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273444 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization