BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190404 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05741
    Event Type
    Injury
    Date Received
    July 25, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED "DECREASED THERAPEUTIC BENEFIT OR PRESENTED WITH VISIBLE SIGNS AND/OR SYMPTOMS OF DECREASED THERAPEUTIC BENEFIT." ON (B)(6) 2011, IT WAS REPORTED THAT DEVICE TROUBLESHOOTING WAS PERFORMED ON (B)(6) 2011 AND DEMONSTRATED "NO FLOW THROUGH THE CAP" (CATHETER ACCESS PORT). THE PATIENT WAS GIVEN ORAL MEDICATION TO MANAGE THE INCREASED SPASTICITY AND ITCHING UNTIL SURGERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 TO MANAGE THE WITHDRAWAL SYMPTOMS FROM ITB (INTRATHECAL BACLOFEN THERAPY). ON (B)(6) 2011, A CATHETER REVISION WAS PERFORMED; THE CATHETER HAD ROTATED 90 DEGREES AT THE ANCHOR KINKING THE CATHETER ON THE SUTURE BLOCKING THE FLOW OF BACLOFEN. THE HCP "FREED IT UP" AND THEN DISCONNECTED CATHETER AT THE PIN CONNECTOR; THEN HAD EXCELLENT FLOW. THE PATIENT WAS IN INPATIENT REHAB AT THE TIME OF THIS REPORT; THEY WERE TITRATING HER DOSE TO MEET HER NEEDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R ACCESSORY: MODEL 8590-1, LOT# N213449.| CATHETER: MODEL 8596SC, LOT# N210445016.| CATHETER: MODEL 8709SC, LOT# N211778023.| IMPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER, MODEL: 8709SC, LOT# N211778023| IMPLANTED:| CATHETER, MODEL: 8596SC, LOT# N210445016| IMPLANTED:| ACCESSORY, MODEL: 8590-1, LOT# N213449| IMPLANTED: