BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2853832 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11040
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 2, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUE WITH THE PUMP AND WANTED IT REMOVED. THE PATIENT HAD NOT HAD BACK PROBLEMS BEFORE, BUT WAS HAVING PAIN IN HIS BACK. THE PAIN WAS AT THE PUMP ANCHOR SITE. THE PATIENT HAD A MAGNETIC RESONANCE IMAGE (MRI) THAT SHOWED SCAR TISSUE. THE PATIENT HAD A 'WEIRD' EXPERIENCE WHERE THEY FELT LIKE THE PUMP STOPPED. THE PATIENT WAS AT THE EMERGENCY ROOM (ER), AND WHEN HE WAS PRESSING AND RUBBING ON THE CATHETER HE FELT A FLOOD OF MEDICATION THROUGH HIS BODY. THE PATIENT FELT LIKE HE WAS OVERDOSING. THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT, THE PUMP WAS FOR ABDOMINAL PAIN AND THE PUMP WORKED FOR HIS STOMACH PAIN AT ONE POINT. IN THE LAST SIX MONTHS THE PATIENT'S STOMACH PAIN HAD BEEN WORSE. THE PATIENT'S MEDICATION WAS TURNED DOWN TO DETOX THE PATIENT. THIS IS WHEN THE PATIENT EXPERIENCED A RETURN IN PAIN. THE PATIENT HAD REDUCED BONE MASS AND 'EVERYTHING ELSE.' THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE, DILAUDID (HYDROMORPHONE), KETAMINE, BUPIVACAINE, MIDAZOLAM (VERSED), AND NALOXONE/NARCAN. IT WAS LATER REPORTED THAT THE PATIENT HAD SERIOUS BACK PAIN AT THE CATHETER SITE FOR THE PAST SIX MONTHS. FOLLOWING AN MRI THE PATIENT'S HEALTHCARE PROVIDER (HCP) WAS SUSPECTING INFLAMMATORY MASS. IT WAS UNCLEAR IF IT WAS A GRANULOMA OR NOT. THERE WAS SCAR TISSUE AROUND THE AREA ALONG WITH EARLY SIGNS OF ARTHRITIS AND 'ALL KINDS OF STUFF.' THE HCP REQUESTED THAT THE PUMP BE REMOVED AS SOON AS POSSIBLE. THE PATIENT HAD BEEN TITRATING DOWN AND THE HCP THOUGHT THE BACK PAIN COULD BE RELATED TO THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SCAR TISSUE AT THE ANCHOR SITE OF THE CATHETER. THE SCAR TISSUE WAS CONFIRMED VIA FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI) SCAN DONE ABOUT 3 MONTHS AGO. THEY FOUND SCAR TISSUE ON THE PATIENT'S SPINE; RIGHT AT THE ANCHOR SITE. IT WAS NOTED THAT THE PUMP SHOULD BE EXPLANTED TO AVOID FURTHER COMPLICATIONS AND DAMAGE. THE PATIENT HAD A MIXTURE OF 6 DIFFERENT MEDICATIONS AND NEEDED TO BE WEANED OFF. IN ORDER TO GET RID OF ALL THE MEDICATIONS THE PATIENT HAD TO GO THROUGH DETOXIFICATION. IT WAS INDICATED THAT THE PUMP WAS STILL WORKING. SO FAR TWO 10% REDUCTIONS HAD BEEN DONE AND AFTER THE LAST ONE, THE PATIENT WAS IN BED FOR 10 DAYS. IT WAS NOTED THAT IT'S UNCOMFORTABLE WHEN THEY TITRATE HIM DOWN. THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE DRUGS DELIVERED VIA PUMP WERE; BUPIVACAINE, CLONIDINE, DILAUDID, VERSED, KETAMINE, AND NARCAN. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Required Intervention