BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3040253 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04839
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 11, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PATIENT PROGRAMMER 8835, SERIAL# (B)(4), IMPLANTED: NA, EXPLANTED: NA; CATHETER MODEL 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED LACK OF THERAPEUTIC EFFECT, SHE 'FELT IT NUMB' DURING THE TRIAL BASIS, AND THAT WAS THE ONLY TIME SHE FELT RELIEF. 'EVER SINCE' THE IMPLANT THE PATIENT AND HEALTHCARE PROVIDER (HCP) 'TRIED TO GO UP' TO 'WHERE IT NEEDS TO BE,' IT WAS NOTED THAT 'NOTHING SEEMED TO WORK.' THE PATIENT FELT 'AGGRAVATED,' WAS 'ABOUT READY TO LOSE IT,' AND 'DIDN'T KNOW WHAT ELSE TO DO.' THE HCP 'DETOXED' THE PATIENT BECAUSE THE PATIENT HAD BECOME 'IMMUNE TO THE NARCOTIC,' IT WAS CLARIFIED THAT THE PATIENT HAD BEEN ON A DRUG HOLIDAY, THE LENGTH OF DRUG HOLIDAY WAS NOT REPORTED. THE PATIENT FELT LIKE SHE HAD 'A STICK UP HER BUTT ALL THE TIME,' 'SOMETIMES IT'S WORSE THAN OTHERS,' SOMETIMES 'IT JUST JABS IN ME,' ACROSS HER LOWER BACK AND DOWN HER RIGHT LEG,' AND SHE 'STILL CAN'T REALLY FEEL ALL THE MUCH OF' HER RIGHT LEG. IT WAS LATER ADDED THAT A CATHETER DYE STUDY REVEALED DISTAL CATHETER RETRACED/DISLODGEMENT/MIGRATION. A CATHETER REVISION WAS DONE. IT WAS UNCLEAR EXACTLY WHAT THE SIGNS AND SYMPTOMS RELATED TO THE EVENT WERE BUT IT WAS NOTED THAT THEY BEGAN 'SHORTLY AFTER PUMP INSERTION (B)(6) 2013.' PATIENT OUTCOME WAS NOT NOTED. THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143511 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention