BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1162834 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05837
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    May 15, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION. THE 7.5 CENTIMETER SUTURELESS CONNECTOR ASSEMBLY; 1.5 CENTIMETER SEGMENT; 54.5 CENTIMETER SEGMENT AND 10.5 CENTIMETER SEGMENT TO THE DISTAL TIP WERE RETURNED FOR ANALYSIS. THE CATHETER PASSED PATENCY AND PRESSURE TESTING. UNDER A MICROSCOPE INSPECTION, A CIRCULAR INDENT WAS SEEN IN THE BOTTOM OF THE CUP OF THE SUTURELESS CONNECTOR WHICH WAS NOTED TO BE CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. ALL OF THE INDENT IS LOCATED IN THE SILICONE MATERIAL OF THE CUP OF THE SUTURELESS CONNECTOR. THIS APPEARED TO INDICATE THAT THE CONNECTION BETWEEN THE SUTURELESS CONNECTOR AND THE PUMP'S OUTLET PORT WAS POSSIBLY OCCLUDED. FINAL DEVICE ANALYSIS REVEALED PUMP CONNECTOR ANOMALY. RESULTS CODE USED FOR THE CATHETER. THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, PROPER CONNECTION OF SUTURELESS CONNECTOR INTRATHECAL CATHETERS, PHYSICIAN COMMUNICATION (JUNE 2008) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DAILY DOSE WAS "STEADILY INCREASING". THE PUMP AND CATHETER WERE REPLACED. ADDITIONAL INFORMATION FROM A DISCHARGE SUMMARY RECEIVED FROM THE HEALTH CARE PROVIDER. SHE WAS DISCHARGED HOME IN 2008, FOLLOWING CATHETER REPLACEMENT, WITH THE PUMP SETTING AT LIORESAL 2000 MCG/ML AT 400 MCG/DAY SIMPLE CONTINOUS. HOWEVER, THE PATIENT CONTINUED TO HAVE DIFFICULTY PRIMARILY AT NIGHT AND REQUIRED ORAL BACLOFEN, AS WELL AS VALIUM. CONSEQUENTLY, THE PATIENT CAME BACK TO THE HOSPITAL ON THE FOLLOWING MONTH, FOR REEVALUATION. SHE WAS READMITTED ON TWO DAYS LATER, AND UNDERWENT REPLACEMENT OF HER INTRATHECAL BACLOFEN PUMP AND CATHETER. A SYNCHROMED II 40 ML RESERVOIR PUMP WAS PUT INTO PLACE WITH THE CATHETER TIP AT T7. THIS UNDERWENT WITHOUT COMPLICATION. FOLLOWING SURGERY, SHE WAS TRANSFERRED OVER TO THE PHYSICAL MEDICINE AND REHABILITATION SERVICE FOR FURTHER MANAGEMENT OF HER PUMP. OVERALL, SHE TOLERATED THE PUMP FINE. THE INCISION HEALED WELL. HER INTRATHECAL BACLOFEN DOSE WAS SLOWLY INCREASED TO A FINAL VALUE OF 195 MCG/DAY (2000 MCG/ML) SIMPLE CONTINUOUS. THE PATIENT DID HAVE AN EPISODE OF VOMITING; HOWEVER, UPON DISCHARGE LOOKED FAIRLY GOOD WITH NO NAUSEA OR VOMITING. HER PAIN CONTROL WAS DOING WELL. IN ADDITION, DURING THE HOSPITAL STAY, THE PATIENT HAD SOME MIDSTERNAL CHEST PAIN. THIS WAS THOUGHT TO BE RELATED TO CONSTIPATION, AS WELL AS SOME REFLUX AND SOME MILD COSTOCHONDRITIS; CLEARED WITH IBUPROFEN. UPON DISCHARGE, FOUR DAYS LATER, SHE HAD MINIMAL TO NO COMPLAINT OF CHEST PAIN. HER BOWEL AND BLADDER WERE STABLE UPON DISCHARGE. HER APPETITE WAS GOOD AND SHE HAD NO PAIN NOTED THROUGHOUT. NO SIGNS OF INFECTION. NEUROLOGICAL: PASSIVE RANGE OF MOTION OF LOWER EXTREMITIES TONE IS AT WORST 1/4 ON A MODIFIED ASHWORTH SCALE. THE PATIENT IS ABLE TO GO FROM A SIT-TO-STAND POSITION WITH MILD ASSISTANCE FROM HER MOTHER. SHE DOES WALK WITH A REVERSE WALKER AND RETURNS TO HER BASELINE WALKING. SHE DOES USE BILATERAL ANKLE-FOOT ORTHOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| CATHETER MODEL 8709SC LOT# N117856018