BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191399 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10325
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 20, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # L56457, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BELIEVED THE CATHETER WAS KINKED AND NOT SHOWING UP ON THE DYE STUDY. REPORTEDLY, THE TWO DYE STUDIES DID NOT INDICATE ANY CATHETER ISSUE. THE HEALTH CARE PROVIDER HAD KEPT TURNING THE PUMP UP, HOWEVER, THIS DID NOT HAVE ANY EFFECT ON THE PATIENT. FURTHER, THE PATIENT REPORTED THE PUMP HAD NOT BEEN WORKING AND HE HAD TROUBLE WITH IT FOR THE PAST YEAR. WHEN THE PATIENT ¿STRAINS¿ IN CERTAIN POSITION OR LEANED FORWARD ¿GOT ALL THE MEDICINE AT ONE TIME¿ AND ALMOST "KNOCKED HIM OUT." REPORTEDLY, THE PATIENT COULD TAKE HIS LEGS PUT THEM BEHIND HIS HEAD AND ¿TIE WITH KNOT WITH THEM.¿ THE PHYSICIAN HAD BEEN MADE AWARE OF THIS AND REPORTEDLY TURNED THE PUMP UP MORE AS IT WAS THOUGHT THE PATIENT HAD NOT BEEN GETTING ENOUGH MEDICINE. HOWEVER, THE PATIENT STATED HE HAD GOTTEN ¿WAY TOO MUCH.¿ WHEN ¿IT DOES WORK¿ THE PATIENT STATED HE DID NOT ¿KNOW WHERE I¿M AT.¿ THE PATIENT HAD BEEN TO THEIR PHYSICIAN THREE TIMES IN ONE WEEK AND ¿ALL THEY DO IS KEEP TURNING IT UP.¿ THIS DEVICE SYSTEM DELIVERED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291253 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other