BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2633689 · Received June 28, 2012

    Report

    Report Number
    3004209178-2012-04935
    Event Type
    Injury
    Date Received
    June 28, 2012
    Report Date
    June 1, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, SERIAL # (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8591-38, LOT # D17878, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. THE MODEL 8703W CATHETER WAS RETURNED IN 2 SEGMENTS. ANALYSIS OF THE CATHETER FOUND SEGMENT 1 HAD 3 DIFFERENT AREAS OF ABRASION, APPROXIMATELY 3.5, 8.5 AND 13.5 CM FROM ITS PROXIMAL END. NONE OF THE ABRASION AREAS WERE WORN DOWN TO THE INNER LUMEN, SO NO LEAKING WAS SEEN WITH THIS SEGMENT. SEGMENT'S 2'S DISTAL PORTION HAD TWO SLICE CUTS, 24.5 AND 25 CM FROM ITS DISTAL TIP. THESE SLICE CUTS APPEARED TO BE EXPLANT-RELATED AND GO THROUGH TO THE INNER LUMEN. ANALYSIS OF THE MODEL 8703W CATHETER ALSO FOUND THAT THE CATHETER BODY HAD BEEN INCORRECTLY ASSEMBLED DURING USE. A SUTURE COULD BE SEEN THAT WAS PLACED DIRECTLY ON THE CATHETER ON SEGMENT 2'S DISTAL PORTION. PLUS A WITNESS MARK CAN BE SEEN ON THE PROXIMAL PORTION OF SEGMENT 2 WHERE IT APPEARS A SUTURE HAD BEEN PLACED DIRECTLY ON THE CATHETER. THE STRAIN RELIEF SHROUD WAS NOT ATTACHED TO SEGMENT 2 AS RECEIVED, HOWEVER, A MARKING ON ONE OF THE TWO THE SUTURE RING AREAS OF THE STRAIN RELIEF SHROUD INDICATES A SUTURE WAS PLACED ON THE PROXIMAL SIDE OF THE SHROUD AT SOME POINT IN TIME. THIS WOULD INDICATE THAT THE STRAIN RELIEF SHROUD HAD BEEN USED AS PART OF THE IMPLANT. FINALLY, ANALYSIS OF THE MODEL 8703W CATHETER ALSO FOUND A HOLE OR TEAR IN THE CATHETER BODY, CAUSED BY THE CONNECTOR PIN POKING THROUGH. A HOLE WAS SEEN IN THE DISTAL PORTION OF SEGMENT 2 CORRESPONDING TO AN AREA WHERE THE METAL PIN OF THE PIN CONNECTOR COMES TO AN END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP POCKET SEROMA. THE PATIENT DENIED HEADACHES OR OTHER WITHDRAWAL SYMPTOMS. IT WAS 'UNKNOWN' IF THERE WAS PATIENT INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE CATHETER WAS REPLACED. THE REASON FOR CATHETER REMOVAL WAS UNKNOWN, BUT IT WAS NOTED THAT FLUID FILLED THE POCKET AT THE PUMP SITE. THE PHYSICIAN OPENED THE PUMP POCKET AND EXPLORED THE POCKET TO TRY TO FIND THE SOURCE OF THE FLUID, BUT THE PHYSICIAN'S OPINION ABOUT THE SOURCE OF THE FLUID WAS NOT PROVIDED. THE PATIENT OUTCOME WAS NOT PROVIDED. 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
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention