BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230474 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06359
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S SYMPTOMS INCLUDED A RECENT INCREASE IN THE PATIENT'S USUAL PAIN, BAND-LIKE OR RADICULAR PAIN AT THE THORACIC LEVEL, NEW OR DIFFERENT SENSORY COMPLAINTS OR PARESTHESIA IN THE LEFT FLANK, AND DEEP INTERNAL BAND-LIKE ITCHING. A T10 EPIDURAL CYST WAS FOUND VIA X-RAY. THE MASS WAS REMOVED OR SURGICALLY EXPLORED ON (B)(6) 2011; THE CATHETER WAS REMOVED ON (B)(6) 2011. THE OPERATIVE FINDINGS SHOWED "T10 EPIDURAL CYST, SCAR AT CATHETER TIP". NO CULTURES WERE DONE. THE PATIENT'S PRESENT STATUS WAS UNKNOWN; THE PATIENT HAD NOT RETURNED TO THE PAIN CLINIC SINCE (B)(6) 2011 PRE-SURGERY. IT WAS ALSO NOTED THAT THE PATIENT HAD A PUMP POCKET REVISION TO MOVE THE PUMP TO THE LEFT SIDE BECAUSE THE RIGHT SIDE POCKET HAD ERODED THROUGH THE SKIN. THE PUMP WAS DELIVERING MORPHINE (50 MG/ML, 21.919 MG/DAY) FROM (B)(6) 2011 TO (B)(6) 2011.

    Description of Event or Problem · 1

    AN INFLAMMATORY MASS WAS REPORTED. THE DRUG BEING DELIVERED VIA THE DRUG DELIVERY SYSTEM WAS UNK AT THE TIME OF THIS REPORT. ADDITIONAL INFO 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
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R IMPLANTED:| EXPLANTED:| CATHETER EXPLANT:| CATHETER: MODEL 8711, LOT# N083395022