BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2900330 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00266
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REMOVED IN (B)(6) 2011, DUE TO INFECTION AROUND THE AREA OF THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT SWELLING, ERYTHEMA AND PAIN WERE NOTED IN RIGHT LOWER QUADRANT OF ABDOMEN, THOUGH THERE WAS NO TENDERNESS OVER THE PUMP. AN ABSCESS WAS 'NEAR' HIS 'OLD' INCISION FROM SIX YEARS AGO AND 'APPROXIMATELY AN INCH AND A HALF FROM A RECENT INCISION' FROM AN UNRELATED LUMBAR INTERBODY FUSION. THE AREA 'CONTINUED' TO FESTER AND STARTED DRAINING AND AN EXPLORATORY SURGERY WAS DONE. DURING SURGERY AN 'ABDOMINAL WALL ABSCESS INVOLVING THE LATERAL ASPECT OF THE INTRATHECAL CATHETER WITH TUNNELING WHICH INVOLVED THE PUMP' WAS FOUND. IT WAS NOTED AN 'INCISION AND DRAINAGE OF LATERAL WALL ABSCESS WITH REMOVAL OF CATHETER AS MUCH AS POSSIBLE AND REMOVAL OF INTRATHECAL PUMP.' IT IS UNCLEAR IF SOME CATHETER REMAINS IN THE PATIENT. THERE WAS 'NOT MUCH PURULENCE ALONG THE CATHETER'S TRACT GOING MEDIALLY.' THE PUMP WAS 'DRY,' NO EVIDENCE OF ABSCESS PRESENT AT PUMP. THE MESH COVERING THE PUMP WAS ALSO REMOVED. THE WOUND WAS IRRIGATED THOROUGHLY, 'GOOD HEMOSTASIS WAS OBTAINED. THE PATIENT 'TOLERATED THE PROCEDURE WELL.' THE CATHETER, PUMP AND MESH WERE SENT FOR CULTURES. NO RESULTS WERE REPORTED. IT WAS ALSO NOTED THAT BLOOD AND URINE CULTURES SHOWED NO GROWTH. THE PUMP, CATHETER AND MESH WERE SENT FOR CULTURES, NO RESULTS WERE REPORTED. 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
    7406 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention