BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5550479 · Received April 6, 2016

    Report

    Report Number
    3004209178-2016-06145
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Date of Event
    February 18, 2016
    Report Date
    May 13, 2016
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE APPOINTMENT ON (B)(6) 2016 WAS INTENDED TO BE A SIMPLE PUMP REFILL AND REPROGRAMMING. THAT WAS ACCOMPLISHED. FOUR CC'S OUT OF AN ESTIMATED 4.1 CC OF OLD HYDROMORPHONE SOLUTION WAS SUCCESSFULLY REMOVED AND 20 CC'S OF HYDROMORPHONE SOLUTION CONTAINING 20 MG/CC WAS INFUSED. THE HCP ALSO INCREASED THE PUMP DOSE BY 9% TO 1.598 MG/24 HOURS. AN EXTENSIVE CONVERSATION WAS HAD REGARDING THE USE OF ORAL OPIATES. UNKNOWN TO THE HCP, THE PATIENT HAD BEEN USING 5 DOSES OF 30 MG OXYCODONE TABLETS PER DAY. IT WAS REPORTED THAT THE PATIENT WAS UNSURE WHETHER THEY WERE LONG-ACTING OR SHORT ACTING DOSES. IT WAS INDICATED TO THE PATIENT THAT TYPICALLY, THAT BEHAVIOR WOULD BE GROUNDS FOR DISMISSAL FROM THE HCP'S PRACTICE, HOWEVER, IT WAS THOUGHT THAT THE PATIENT WOULD HAVE A DIFFICULT TIME GETTING ANYONE ELSE TO TAKE CARE OF HER PUMP AND THEY WERE STILL IN THE PROCESS OF TITRATING HER PUMP. IT WAS REPORTED THAT THE PATIENT HAD LEARNED ON THE INTERNET THAT SOME DOCTORS PRESCRIBED ORAL WHEN NECESSARY OPIOID MEDICATIONS FOR BREAKTHROUGH IN PATIENTS WITH INTRATHECAL OPIATE PUMPS. IT WAS REVIEWED THAT WAS NOT THE STANDARD OF CARE IN (B)(6). IT WAS STATED THAT IF THE PATIENT SAW ANOTHER PAIN SPECIALIST WHO WOULD BE WILLING TO PRESCRIBE LOW-DOSE ORAL OPIATES, AS LONG AS THE TWO HCP'S WERE SHARING MEDICAL INFORMATION, IT WOULD BE ACCEPTABLE TO THE HCP. THE HCP'S GOAL FOR THE PATIENT WAS TO ELIMINATE ALL ORAL OPIATES WITH APPROPRIATE SLOW, STEADY TITRATION OF THE INTRATHECAL HYDROMORPHONE PUMP DOSE. THE PATIENT WAS TOLD THAT THE HCP WOULD BE CHECKING A URINE SPECIMEN IN (B)(6) 2016, AND IF ANY ORAL OPIATE MEDICATIONS SHOWED UP IN HER URINE DRUG TESTING, IT WOULD BE GROUNDS FOR DISMISSAL FROM THE PRACTICE UNLESS IT WAS MADE AWARE TO THE HCP THAT ANOTHER PHYSICIAN WAS PRESCRIBING ORAL OPIATES. IT WAS NOTED IF THE PATIENT WAS UNABLE TO TAPER OFF ORAL OPIATES AND WOULD LIKE TO SEE ANOTHER HCP TO BE EVALUATED FOR SHORT-ACTING OPIATES FOR BREAKTHROUGH PAIN, WHICH THE PUMP HCP WOULD NOT PRESCRIBE, THAT WOULD BE ACCEPTABLE. THE HCP WAS UNABLE TO ASCERTAIN THE NEXT PUMP REFILL DATE AFTER REFILLING AND REPROGRAMMING. THEY WOULD CHECK WITH THE DEVICE MANUFACTURER REPRESENTATIVE (REP) AND HAVE THE PATIENT COME IN FOR INTERROGATION OF THE PUMP TO ESTABLISH HER NEXT LOW RESERVOIR ALARM DATE. IT WAS FURTHER REVIEWED WITH THE PATIENT THAT THE PATIENT WAS AT SIGNIFICANTLY HIGHER RISK FOR MORBIDITY OR EVEN MORTALITY FROM OVERDOSE DUE TO THE COMBINED USE OF ORAL OPIATES AND THE PUMP. AN EVZIO DEVICE WAS BRIEFLY DISCUSSED, HOWEVER THE PATIENT WAS QUITE SURE SHE COULD NOT AFFORD EVEN THE CO-PAY. IT WAS NOTED THAT IF SHE TAPERED OFF THE ORAL OPIATES, SHE WOULD NOT NEED THE EVZIO DEVICE UNLESS IT WAS A MALFUNCTION OF THE PUMP WHICH WOULD BE "EXTRAORDINARILY RARE". THE DISCUSSION OF A POSSIBILITY OF AN EVZIO DEVICE WOULD BE CONTINUED IN THE FUTURE. THE HCP FILLED THE PUMP WITH 20 MG/ML STRENGTH HYDROMORPHONE TO INCREASE THE TIME BETWEEN PUMP REFILLS. THE REASON FOR THE APPOINTMENT ON (B)(6) 2016 WAS A REEVALUATION OF THE PATIENT WITH PREVIOUSLY VERY SEVERE HIGH-LEVEL DURABLE PAIN WHO HAS AN INTRATHECAL BACLOFEN PUMP. CLINICAL REEVALUATION WAS CARRIED OUT AS WELL AS PUMP INTERROGATION AND DOSE ADJUSTMENT. THE PATIENT WAS SEEN IN FOLLOW-UP ON (B)(6) 2016 REGARDING HER CHRONIC PAIN SITUATION AS WELL AS TO UPDATE HER INTRATHECAL HYDROMORPHONE PUMP DOSE. THE HCP RECOGNIZED THAT HE HAD MADE A DOSING MISTAKE FOLLOWING THE REFILL ON (B)(6) 2016. THE HCP NEGLECTED TO CHANGE THE CONCENTRATION OF THE MEDICINE ON THE PROGRAMMER TO REFLECT THE INCREASE IN CONCENTRATION TO 20 MG/ML FROM 10 MG/ML. THE PATIENT WAS ALSO ADVISED TO STOP TAKING OXYCODONE WHICH WAS BEING DOSED AT APPROXIMATELY 150 MG/24 HOURS. BECAUSE THE HCP DID NOT CHANGE THE CONCENTRATION IN THE PROGRAMMER, THE RELATIVE DOSE WAS DOUBLED. THE HCP HAD CALCULATED THE DOSE OF 1.589 MG/DAY. THE HCP INTERROGATED THE PUMP AND INCREASED THE DOSE TO 1.759 MG/DAY PRIOR TO RECOGNIZING THAT HE HAD NEGLECTED TO CHANGE THE CONCENTRATION. THE HCP CHANGED THE PUMP SETTINGS FOLLOWING CALLING THE MANUFACTURER TO CONFIRM THAT THE DOSE WAS RELATIVELY DOUBLED. THE PATIENT'S TRUE DOSE HAD BEEN, SINCE APPROXIMATELY 56 HOURS FOLLOWING THE (B)(6) 2016 APPOINTMENT, 3.178 MG/24 HOURS. IT WAS BELIEVED THAT THIS SERENDIPITOUSLY ALLOWED THE PATIENT TO TAPER OFF ORAL OPIATES WITHOUT SIDE EFFECTS AND SOMEWHAT IMPROVED EFFICACY. MODERATE FUNCTIONAL IMPAIRMENT SECONDARY TO RIGHT SCIATIC NOTCH PAIN AND PAIN RADIATING DOWN THE LATERAL PORTION OF HER PROXIMAL RIGHT LOWER LIMB NOT PAST THE PATIENT'S KNEE WAS REPORTED. THE TROCHANTERIC AREA WAS IMPROVED. THE PATIENT WAS PARTICIPATING IN PHYSICAL THERAPY. THE PATIENT HAD BILATERAL LUMBOSACRAL JUNCTION PAIN WITH WALKING. THE PATIENT DID NOT NOTICE ANY SIDE EFFECTS OR CHANGES IN HER COGNITIVE STATUS, MOTOR STATUS, OR SENSORY STATUS WITH THE CHANGE IN DOSE. THE PATIENT'S PAIN REMAINED ABOVE 5 MOST OF THE TIME, BUT OVERALL WAS IMPROVED COMPARED TO THE INTRATHECAL BACLOFEN PUMP PLACEMENT WHEREAS THE PATIENT REPORTED VERY HIGH LEVELS OF DURABLE PAIN. THE HCP RE-INTERROGATED THE PUMP AND INCREASED THE DAILY DOSE OF INTRATHECAL HYDROMORPHONE TO 3.505 MG/DAY WITH NO BOLUS. THE PATIENT'S NEW ALARM DATE WAS (B)(6) 2016. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2016 WHICH WOULD BE THE PUMP REFILL DATE. A 14-POINT REVIEW OF SYSTEMS WAS OBTAINED AND WAS SIGNIFICANT FOR FATIGUE, SWEATING, ARTHRITIS/JOINT PAIN, DEPRESSION, ANXIETY, STRESS, MEMORY LOSS, AND SLEEP DISTURBANCE. THE PATIENT'S HEAD WAS ATRAUMATIC AND NORMOCEPHALIC. CRANIAL NERVES II, III, IV, V, VI,VII, XI, AND XII WERE NORMAL TO INSPECTION. THERE WAS NO SEVERE NASAL CONGESTION. THE SCLERAE WERE ANICTERIC AND NON-INJECTED. PUPILS WERE NEITHER DILATED NOR CONSTRICTED. INSPECTION OF THE PATIENT'S NECK SAW NO CERVICAL ADENOPATHY. THE TRACHEA WAS MIDLINE. THERE WAS NO ORAL MUCOSAL DEHYDRATION TO OBSERVATION. RESPIRATIONS WERE EVEN AND UNLABORED. THE PULSE WAS REGULAR. THE ABDOMEN WAS NOT EXAMINED. THERE WAS NO CLUBBING OR CYANOSIS IN THE EXTREMITIES. THERE WAS NO UNEXPECTED PERIPHERAL EDEMA IN AREAS INSPECTED. NO SIGNIFICANT RASHES OR LESIONS WERE NOTED. THERE WERE NO CUTANEOUS ABNORMALITIES CONSISTENT WITH A NEUROMUSCULAR DIAGNOSIS IN AREAS INSPECTED. THERE WAS NO EVIDENCE OF FASCICULATIONS OR ATROPHY IN AREAS EXAMINED. HIP RANGE OF MOTION DID NOT RE-CREATE MUCH IN THE WAY OF PAIN. THERE WAS NO UNEXPECTED LORDOSIS, SCOLIOSIS, OR KYPHOSIS OF THE CERVICAL, THORACIC, OR LUMBAR SPINE. BILATERALLY, IPSILATERAL LUMBAR SPINE RANGE OF MOTION RECREATED IPSILATERAL LUMBOSACRAL JUNCTION PAIN. DETAILED MENTAL STATUS TESTING WAS NOT DONE, HOWEVER, THE PATIENT WAS ABLE TO GIVE A GOOD HISTORY AND TIMELINE REGARDING SYMPTOMS. THERE WAS A SIGNIFICANTLY LESS ANTALGIC MOVEMENT AND GAIT PATTERN AT THAT POINT, PARTICULARLY COMPARED TO PRIOR TO THE PLACEMENT OF THE PUMP. MOVEMENTS WERE WELL-COORDINATED WITH NO EVIDENCE OF MOVEMENT DISORDER IN THE FACIAL MUSCULATURE, CERVICAL SPINE, OR LIMBS. THERE WAS NO OBSERVATIONAL EVIDENCE OF SIGNIFICANT SPASTICITY OR TREMOR IN THE UPPER OR LOWER LIMBS. NO MYOTOMAL WEAKNESS WAS NOTED DURING AMBULATION. THE PATIENT WAS WELL GROOMED, WELL-DRESSED, AND MADE GOOD EYE CONTACT. AFFECT IS APPROPRIATE TO CIRCUMSTANCES. PAIN BEHAVIOR WAS NOT NOTED. THE PATIENT'S PAST MEDICAL AND SURGICAL HISTORY INCLUDED DEPRESSION/ANXIETY, PREVIOUS PSYCHIATRIC CARE, HYSTERECTOMY, BACK SURGERY FUSION 2014, SACROILIAC JOINT FUSION, AND BURSA REMOVAL OF RIGHT HIP. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED DEXTROAMPHETAMINE 10 MG, ACYCLOVIR 200 MG, OMEPRAZOLE 20 MG, PROPANOLOL 40 MG, QUETIAPINE FUMARATE 100 MG, FISH OIL 1000 MG, B COMPLEX MIX, MAGNESIUM 500 MG, CALCIUM WITH VITAMIN D, PROZAC 60 MG, AND SEROQUEL 300 MG. THE PATIENT WAS ALLERGIC TO THORAZINE AND REGLAN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP), REGARDING A (B)(6) YEAR OLD FEMALE PATIENT RECEIVING INTRATHECAL MORPHINE 20MG/ML AT 3.18MG/DAY VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE OF THE DEVICE WAS FOR NON-MALIGNANT PAIN AND CHRONIC LOWER BACK PAIN. THE CONCOMITANT MEDICATIONS AND PATIENT HISTORY WERE NOT REPORTED. IT WAS REPORTED THAT ON (B)(6) 2016 THERE WAS A BRIDGE BOLUS ERROR, AS THE HEALTH CARE PROVIDER (HCP) ERRONEOUSLY BYPASSED THE BRIDE BOLUS WHEN UPDATING THE CONCENTRATION FROM MORPHINE 10MG/ML AT 1.59MG/DAY. THE HCP HAD FILLED THE PUMP WITH 20MG/ML OF MORPHINE, BUT DID NOT CHANGE THE PROGRAMMING OR DO A BRIDGE BOLUS. IT WAS NOTED THAT THE OLD MEDICATION WOULD HAVE TAKEN APPROXIMATELY 56 HOURS TO DELIVER. THE HCP REPORTED THAT THE PATIENT DID WELL ON THE HIGHER DOSE, BUT THE HCP WOULD ADJUST THE DOSE ACCORDINGLY. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207576 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR