BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2942052 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01262
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE NURSE NOTED THIS PATIENT HAD SIDE EFFECTS, OVERDOSE SYMPTOMS, AFTER A REFILL. THERE WAS NO POCKET FILL AS THIS WAS VERIFIED. IT WAS FURTHER BELIEVED THAT THE ISSUE WAS WITH THE COMPANY REFILL NEEDLES. THE HEALTH CARE PROVIDER HAS SWITCHED REFILL KITS TO ONES WITH ALL-METAL NEEDLE AND SINCE HAVE NOT HAD FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIDE EFFECTS INCLUDING DIZZINESS, DROWSINESS, SLURRED SPEECH, INCREASED HEAR RATE, AND INCREASED BLOOD PRESSURE WERE EXPERIENCED BY PATIENT'S AFTER PUMP REFILLS. IT WAS UNCLEAR EXACTLY WHICH OF THOSE SYMPTOMS WERE EXPERIENCED BY THIS PATIENT. OVERDOSE SYMPTOMS AND AN ALTERED MENTAL STATUS WERE NOTED. THE PATIENT'S PUMP WAS REPROGRAMMED AND THE PUMP WAS REDUCED. THE PATIENT'S STATUS AS OF THE DATE OF THIS REPORT WAS NOTED TO BE ALIVE AND WITHOUT INJURY. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. HCP REPORTED PATIENT SIGNS AND SYMPTOMS: CONFUSION, SLEEPY, SLURRED SPEECH, INCREASED BLOOD PRESSURE AND PULSE. IT WAS REPORTED THAT SYMPTOMS DECREASED BEFORE THE PATIENT WENT TO ER. THE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVICAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) DIDN'T HAVE TIME TO PROVIDE SPECIFIC PATIENT, EVENT OR DEVICE INFORMATION REGARDING THE REFILL EVENTS. IT WAS NOTED THE HCP'S CLINIC MANAGED "ABOUT" TWO HUNDRED PUMPS, DOING SEVENTY TO EIGHTY REFILLS PER MONTH. THE HCP CONFIRMED HE DOES NOT USE THE MEDTRONIC NEEDLES FOR REFILLS AND PREFERS TO USE AN ALL METAL NEEDLE. THE HCP REPORTEDLY FELT THE REFILL KIT WAS SUB-STANDARD, THE NEEDLE WAS "FLIMSY" AND FELT THAT HIS PATIENTS HAVE "SUBCUTANEOUS ABSORPTION" WHEN THE NEEDLE IS BEING REMOVED FROM THE PUMP/PATIENT. IT WAS NOTED THE HCP WOULD LIKE A "BETTER" TWO INCH STEEL NEEDLE AND A LOWER PRICE. IT WAS LATER REPORTED THAT THE HCP WANTED ALL METAL NEEDLES INCLUDED WITH HIS REFILL KITS OR A LARGE PACK OF REFILL TEMPLATES TO USE WITH ANOTHER COMPANY'S REFILL KIT. CURRENTLY, THE HCP HAD TO USE TWO SEPARATE KITS FOR EACH REFILL SO AS TO GET AN ALL METAL NEEDLE AS WELL AS THE REFILL TEMPLATE. IT WAS NOTED THE METAL NEEDLE THE HCP WAS USING FROM ANOTHER COMPANY WAS SIMILAR TO THE METAL HUB NEEDLE THAT IS INCLUDED IN THE PUMP PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45936 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other