BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203529 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11208
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HEALTH CARE PROVIDER (HCP) ORDERED A MEDICAL PROCEDURE. THE PATIENT WOULD NOT PROVIDE DETAILS REGARDING THE PROCEDURE. IT WAS NOTED THE PATIENT COULD NOT GO THROUGH THE MEDICAL PROCEDURE WITH HAVING OPIOIDS IN HIM. THE PATIENT REPORTEDLY NEEDED TO ¿AT LEAST HAVE IT SHUT OFF AND DRAINED. AND THEN YOU KNOW THE DECISION TO TURN IT BACK ON COULD BE MADE LATER¿. IT WAS NOTED THE PATIENT HAD A MOTORCYCLE ACCIDENT, THE TIMEFRAME WAS NOT PROVIDED, AND THE PATIENT HAD BEEN TOLD NOT TO GO THROUGH ANY SURGERY BECAUSE IT ¿WOULD CUT OUT THOSE BARS¿. IT WAS NOTED THE PATIENT ¿USUALLY GOT MORE TIME TO DECIDE IF THEY WANT TO PUMP BUT¿ THE PATIENT¿S HCP ¿JUST PUT THE PATIENT IN THE HOSPITAL¿. NO FURTHER INFORMATION WAS PROVIDED AND IT WAS NOTED THAT THE PATIENT DIDN¿T WANT HIS HISTORY ¿ALL OVER THE PLACE¿. IT WAS AGAIN AS PREVIOUSLY REPORTED NOTED THE PATIENT NEVER REALLY HAD THE RELIEF HE THOUGHT HE SHOULD GET. IT WAS REPORTED THE HCP HAD DONE X-RAYS TO SEE TO ¿SEE IF THE CATHETER IS WORKING AND WE¿VE HAVE HAD PEOPLE IN X-RAY SAY ¿OH THAT IS BAD¿ BUT DR. LIN ALWAYS SAYS EVERYTHING IS FINE¿. IT WAS THEN REPORTED THE PATIENT HAD STATED ¿I¿VE GOT TO HAVE A MEDICAL PROCEDURE DONE¿. THE PATIENT HAD REQUESTED THAT THE PUMP NEEDED TO BE DRAINED AND SHUT OFF. WHEN FURTHER INFORMATION WAS ATTEMPTED TO BE OBTAINED IT WAS STATED ¿THAT¿S NOBODY¿S BUSINESS THAT IS PRIVACY ACT¿. IT WAS NOTED THE PATIENT COULD NOT HAVE DILAUDID IN HIM DURING THE PROCEDURE. IT WAS THEN REPORTED THE PATIENT AND THEIR HCP DID NOT ¿SEE EYE TO EYE¿. THE PATIENT HAD TOLD THE HCP TO REMOVE THE DEVICE AFTER 2 WEEKS. IT WAS NOTED THE PATIENT HAD MAJOR PROBLEMS, ¿BIPOLAR, MANIC DEPRESSIVE, SCHIZOPHRENIC, I¿M REALLY STARTING TO LOSE IT¿IT¿S NOBODY¿S BUSINESS WHAT¿S WRONG WITH ME. I WANT SOMETHING DONE OR I¿M GOING TO TAKE IT TO THE NEXT STEP¿. THE REPORTER PLANNED TO CALL THE HCP TO EXPLAIN ¿WHAT IS GOING ON AND GO FROM THERE¿.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT DISMISSED HIS PHYSICIAN. THE PATIENT REPORTED THAT THE PUMP WAS DELIVERING " BACLON, AND IT'S GOT CLONDINE, AND IT'S GOT NITRO BUT IT HAS NO NARCOTICS AT ALL." THE PATIENT NOTED HE HAD A LOT OF ¿PROBLEMS¿ GOING ON. HE HAD CALLED HIS PHYSICIAN THE WEEK PRIOR TO THIS REPORT AND THE PHYSICIAN WAS TO GET THE PATIENT ¿IN ON AN EMERGENCY.¿ HOWEVER, THE PATIENT WAS FURTHER CONTACTED AND ADVISED NOT TO COME IN AS THERE WERE TOO MANY PATIENTS. THE PHYSICIAN REPORTEDLY HAD SENT THE PATIENT SOME PAIN PILLS. OF NOTE, A PHYSICIAN TOLD THE PATIENT THAT THE ¿BEST THING TO DO¿ WAS TO HAVE THE PUMP SHUT OFF. HOWEVER, THE MANAGING PHYSICIAN ¿MORE OR LESS¿ WOULD NOT SHUT THE PUMP OFF. THE PATIENT WAS SEEKING ANOTHER PHYSICIAN CLOSER TO WHERE THE PATIENT LIVED AS HE WAS CONCERNED REGARDING HIS CARE. THE PATIENT STATED THAT IT WAS HIS BODY AND HE SHOULD BE ABLE TO DO WHAT HE WANTS. THE PATIENT STATED HE WANTED THE PUMP SHUT OFF AS IT HAD CAUSED HIM PAIN AND SUFFERING. IT WAS UNCLEAR TO THE PATIENT WHY HE HAD THE PUMP IF HE COULD BE TAKING ORAL MEDICATION TO ADDRESS HIS ISSUE. THE PATIENT FURTHER REPORTED HE WAS NOT SURE IF HE WOULD HAVE SALINE PUT IN THE PUMP AND LEAVE IT ON UNTIL SOME OF ¿THESE THINGS¿ COULD BE ADDRESSED. IT WAS ALSO REPORTED THAT THE PHYSICIAN¿S OFFICE NOTED NO PUMP ISSUES OR CATHETER ISSUES AND NOTED THAT THIS DEVICE SYSTEM DELIVERED DILAUDID, COMPOUNDED BACLOFEN, BUPIVACAINE, AND CLONIDINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT ¿LIKE THE LAST MAYBE SIX MONTHS THAT THE CATHETER MAY NOT BEIN RIGHT AND DELIVERING THE MEDICINE RIGHT¿ AND THE PATIENT WAS NOT GETTING RELIEF. THE PATIENT HAD BEEN GOING TO THE HEALTH CARE PROVIDER ¿UP TO EVERY THREE MONTHS, FORTY FIVE DAYS¿ AND IT ¿WASN¿T MAKING A DIFFERENCE¿. THE PATIENT WAS REPORTEDLY NOT GETTING THE RELIEF, HE THOUGHT HE SHOULD GET. IT ¿SEEMED¿ TO TAKE THE PATIENT ¿TWO OR THREE¿ HOURS TO BE ABLE TO GET UP AND START MOVING AROUND OR TO DO ¿ANYTHING¿. THE PATIENT HAD NOT TOLD THEIR HEALTH CARE PROVIDER (HCP) AS THE HCP ¿DIDN¿T KNOW¿ HOW TO DEAL WITH/LISTEN TO PROBLEMS. HOWEVER IT WAS THEN REPORTED ¿WE HAVE ASKED A COUPLE TIMES ABOUT THE MEDICINE BEING DELIVERED CORRECTLY¿. THE PATIENT HAD ASKED THEIR HCP FOR ¿BREAKTHROUGH PAIN¿ BUT THE HCP WOULDN¿T GIVE IT TO HIM. IT WAS NOTED THE PATIENT HAD NOT HAD ANY ACCIDENTS OR TRAUMA. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND ¿SOME OTHER MEDICATION, SOME BLOOD PRESSURE MEDICATION¿. 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
    303943 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R