BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4200298 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20353
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703, LOT# J93126036, IMPLANTED: (B)(6) 1994, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THEY WERE HAVING TROUBLE FILLING THE PUMP BECAUSE OF THE ANGLE THE PUMP WAS IN THE POCKET. THE REPORTER WAS UNAWARE OF ANY OTHER SYMPTOMS. THE HCP DID FIND BOWEL IN THE POCKET AND HAD TO REQUEST ON CALL GENERAL SURGEON TO REPAIR BEFORE FINISHING WITH THE REVISION. THE CAUSE OF THE ISSUE WAS REPORTED AS THE PUMP HAD ERODED THROUGH THE BACK OF THE POCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP POCKET HAD BOWEL SHOWING WHEN THE PUMP WAS BEING REPLACED FOR NORMAL END OF SERVICE. GENERAL SURGERY WAS CALLED IN TO ASSIST WITH THE CASE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS INDICATED AS ALIVE, NO INJURY. THE PUMP WAS USED TO DELIVER MORPHINE AND MARCAINE. NO PATIENT SYMPTOMS, INTERVENTIONS OR PATIENT OUTCOME REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT WHILE IN THE PROCESS OF EXCHANGING A PAIN PUMP FOR ELECTIVE REPLACEMENT DUE TO IMPENDING END OF BATTERY LIFE UPON EXTERNALIZING THE OLD PUMP THEY SAW THAT AT THE DEEP ASPECT OF THE CAVITY THERE WERE CLEARLY LOOPS OF BOWEL PROTRUDING THROUGH A VENTRAL HERNIA. PER THE HCP AT THAT POINT THEY NOTED THAT THE PUMP HAD BEEN PLACED RATHER DEEPLY AND IN A VERTICAL RATHER THAN FLAT POSITION. THEY REQUESTED ASSISTANCE FROM THE GENERAL SURGEON TO PERFORM THE CLOSURE OF THE VENTRAL HERNIA. PER THE GENERAL SURGEON IN THE ANTERIOR ABDOMINAL WALL THEY NOTED THAT THERE WERE BOWELS THAT WERE HERNIATING THROUGH THE FASCIAL DEFECT. FOLLOWING CLOSURE OF THE HERNIA A NEW POCKET WAS CREATED FOR THE INTRATHECAL PUMP TO PLACE IN A BETTER POSITION. THE PUMP WAS PLACED BACK WITHIN ITS POCKET WITH THE CATHETER ACCESS PORT AT THE 3 O¿CLOCK POSITION. PER THE HCP DUE TO THE DIFFICULT NATURE OF EXTRACTING THE PUMP FROM ITS AWKWARD POSITION AND THE OTHER NEUROSURGICAL ASPECTS OF THE CASE THE NEUROSURGICAL PORTION OF THE CASE TOOK APPROXIMATELY 45 MINUTES LONGER THAN WOULD BE EXPECTED OF A CASE THIS TYPE. THE PATIENT AS AWAKENED FROM ANESTHESIA, EXTUBATED IN THE OPERATING ROOM AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. IT WAS FURTHER REPORTED THE PATIENT HAD NO HISTORY OF HERNIA. THE INITIAL PUMP HAD BEEN PLACED ¿REALLY DEEP¿, THIS WAS A VENTRAL HERNIA AND THE NEW PUMP WAS PLACED ANTERIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680089 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Other