BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113730 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03901
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    December 23, 2010
    Report Date
    May 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT NEVER HAD THERAPEUTIC EFFECT; THE PATIENT HAD NOT RELIEF SINCE IMPLANT IN DECEMBER. THE PATIENT HAD PAIN AT THE PUMP SITE AND NEW ABDOMINAL SPASMS. ON (B)(6) 2011, A CATHETER DYE STUDY WAS DONE; THERE WAS GOOD FLOW WITH SOME RESISTANCE WHEN PUSHING THE DYE. THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD A GOOD RESULT WITH THE TRIAL. THE PATIENT WAS CURRENTLY AT 400 MCG/DAY OF LIORESAL WITH A 50 MCG BOLUS AND WAS BACK ON ALL ORALS (BACLOFEN 100 MCG/DAY; TIZANIDINE 4 MG/TID ALONG WITH PRN VALIUM). THE PATIENT OUTCOME WAS REPORTED AS "NON-SERIOUS INJURY/ILLNESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization CATHETER: MODEL 8709SC, LOT# N272928007| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED: