BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2568214 · Received May 10, 2012

    Report

    Report Number
    3004209178-2012-03153
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    April 13, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER MODEL 8835, SERIAL# (B)(4); CATHETER MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK . (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD "EXTREME PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO GET FLUID BACK FROM THE NEEDLE THAT WENT INTO THE PATIENT SPINAL CORD. THE HCP COULD NOT EXTRACT THE LIQUID THEY NEEDED IN ORDER TO MAKE SURE THAT ¿THE MEDICINE GOES WHERE IT¿S SUPPOSED TO GO.¿

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PUMP THERAPY WAS NOT WORKING AS EXPECTED. THE HCP COULD NOT FILL OR ASPIRATE THE RESERVOIR WHEN ATTEMPTED ON (B)(6) 2012, THE DATE OF THE FIRST PUMP REFILL AFTER IMPLANT SURGERY. THE HCP INFORMED THE PATIENT HE WASN'T SURE HE WAS GOING TO BE ABLE TO PERFORM THE REFILL ON (B)(6) 2012 BECAUSE "THERE WAS AN ISSUE AT IMPLANT WHERE THE SALINE IN THE PUMP COULD NOT BE EXTRACTED". IT WAS NOTED THE PUMP CONTAINED SALINE AS OF THE DATE OF THE REPORT. THE PATIENT AND REPORTER WERE NOT MADE AWARE OF THIS SITUATION AT THE TIME OF IMPLANT. THE REPORTER INDICATED ADDITIONAL SURGERY MAY BE NEEDED FOR THE PATIENT 'TO REPLACE THIS PUMP.' THE REPORTER REQUESTED THE PUMP TO BE CHECKED. THE REPORTER WAS TRYING TO GET IN CONTACT WITH THE PUMP MANAGING HCP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1