BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3152627 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09018
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED BACLOFEN PUMP AND ¿THEY¿RE GOING TO TAKE ITOUT¿. IT WAS LATER REPORTED THE PATIENT WAS ¿DOING WELL¿. THE PUMP WAS REMOVED BECAUSE OF INFECTION FROM HIS REPLACEMENT A COUPLE OF WEEKS BEFORE. HE WAS GIVEN ORAL BACLOFEN AND OTHER MEDS TO ¿PREVENT WITHDRAWAL¿. IT WAS LATER REPORTED THAT PATIENT WENT TO THE FOLLOW UP VISIT AND HAD STAPLES REMOVED. AT THAT TIME THE INCISION SITE LOOKED FINE. FOUR DAYS LATER THE HOME HEALTH NURSE NOTICED THE SITE WAS RED AND PATIENT HAD A FEVER. THE INFECTION WAS AT THE PUMP SITE. WE WERE NOT NOTIFIED THAT THE PATIENT WAS HAVING THE PUMP EXPLANTED UNTIL THE NEXT DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD AN ONSET OR DIAGNOSIS DATE OF INFECTION OF (B)(6) 2013. THE PATIENT HAD HIS LAST REFILL ON (B)(6) 2013. THE PATIENT DID NOT HAVE MENINGITIS. IT WAS REPORTED PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. THE SIGNS AND SYMPTOMS INCLUDED ¿FEVER (B)(6) 2013, REDNESS (B)(6) 2013, SWELLING (B)(6) 2013, DRAINAGE (B)(6) 2013, PAIN (B)(6) 2013, INCISIONAL WOUND OPENING (B)(6) 2013¿. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET BUT THE ORGANISM CULTURED WAS UNKNOWN. THE TREATMENT OF THE INFECTION INCLUDED IV ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. THE INFECTION WAS RESOLVED BUT THE PATIENT HAD WITHDRAWAL SYMPTOMS INCLUDING SEVERE SPASTICITY, ALTERED MENTAL STATUS, PAIN, SWEATING, RASH AND ITCHING. THE PATIENT¿S RISK FACTORS BEFORE IMPLANT INCLUDED URINARY TRACT INFECTIONS. THE PUMP WAS INFUSING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252255 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention