BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3043515 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04914
    Event Type
    Injury
    Date Received
    April 9, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PUMP WAS REMOVED IN (B)(6) 2010, BECAUSE THE CATHETER CONTINUED TO BREAK OFF/COME LOOSE, 2 TO 3 TIMES AND THEY HAD "ALL KINDS OF TROUBLE WITH IT." THE DRUG IN THE PUMP WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE PATIENT WAS RECEIVING PRIALT (DOSE AND CONCENTRATION UNKNOWN) VIA THE IMPLANTABLE PUMP FOR ARACHNOIDITIS, NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE CATHETER KEPT ¿COMING OFF.¿ HER HEALTHCARE PROVIDER (HCP) HAD TO OPERATE ON HER 2-3 TIMES TO GET ¿THIS THING TO KEEP WORKING.¿ SHE SUFFERED FOR 3 MONTHS AND KEPT TELLING THE HCP IT WAS NOT WORKING. FINALLY, THE PATIENT COULD NOT TAKE IT ANYMORE AND THE PUMP WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146224 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention