BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3893833 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12008
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N336177, IMPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT RECENTLY WENT BACK TO THEIR HEALTHCARE PROVIDER (HCP) BECAUSE THEY HAD BEEN HAVING SOME PROBLEMS AND HAD NOT BEEN GETTING THE DOSAGE CORRECTLY ¿AND THE HCP DID AN ADJUSTMENT¿. THEIR HCP THOUGHT ¿SOMETHING WAS GOING ON¿ AND ORDERED AN MRI FOR (B)(6) 2014. THEY REPORTED THE PUMP WAS ACTING FUNNY AND THEIR HCP KEPT INCREASING THE DOSAGE. THEY ALSO CHANGED THE COMBINATION IN THE PUMP AND ADDED 25% MORE MORPHINE. THE PATIENT WAS NOT GETTING PAIN RELIEF AND THEIR HCP WAS CONCERNED THERE WAS SOME PROBLEM OR OBSTRUCTION. THEY ORDERED A DYE TEST. THE DYE TEST WAS PERFORMED ON (B)(6) 2014 AND INDICATED THE CATHETER MOVED ABOUT TWO TO THREE MILLIMETERS. THE PATIENT STATED THEIR CATHETER WAS NOT SUTURED DOWN IN THE THORACIC VERTEBRA OR INTRATHECAL AREA LIKE IT WAS FOR NORMAL PATIENTS. HIS CATHETER SUTURE WAS DOWN TO THE L5 NERVE ROOT AREA BECAUSE OF PAIN IN THE RIGHT ILIAC JOINT. THE PATIENT SAW A NEUROSURGEON ON (B)(6) 2014. PER THE NEUROSURGEON, THE PATIENT MAY NOT NEED SURGERY TO REPOSITION THE CATHETER BECAUSE OF THE ¿RISK OF SPINAL FLUID¿ WHICH WOULD PRESENT ANOTHER PROBLEM. THE PATIENT STATED THAT THEIR HCP TOLD THEM THAT, DEPENDING ON WHAT THE MRI SHOWED (GRANULOMA, BLOCKAGE, MOVED, TRAPPED), THE PATIENT WILL NEED TO HAVE SURGERY. THEY WERE NOT SURE HOW ONE COULD DEVELOP A GRANULOMA SO QUICKLY SINCE IMPLANT, WHICH WAS DONE 4 MONTHS PRIOR. THE MEDICATIONS INFUSED WERE MARCAINE AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370840 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other