MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

Other components include: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type: catheter.Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.

Event Description

Information was received from a healthcare provider (hcp) and from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving 2000 mcg/ml of lioresal at 242 mcg/day via an implantable pump for intractable spasticity and multiple sclerosis.On (b)(6) 2017, it was reported that the patient was experiencing baclofen withdrawal symptoms.The patient was reportedly experiencing increased spasticity, itching, "bugscrawling on skin", and anxiety.The symptoms occurred gradually, beginning on (b)(6) 2017.The last event in the patient's pump logs was on (b)(6) 2017 and there were no new events in the logs to indicate an issue with the pump.The hcp reported that a medical workup would be performed and that the patient would be admitted.It was later reported again that the patient had symptoms of possible underdose/withdrawal.The patient's managing hcp referred the patient to the er to perform a medical workup for uti versus an issue with the pump.No environmental/external/patient factors that may have led or contributed to the issue were reported.A dye study was to be performed on (b)(6) 2017.The patient's dose was increased to 339 mcg/day with flex dosing by the neurosurgery resident on (b)(6) 2017, but on (b)(6) 2017 the patient presented today as flaccid with possible signs of overdose.The managing hcp planned to wean the dose back down.The issue was not considered resolved at the time of the report.The patient's status was listed as "alive-no injury".Additional information was received on (b)(6) 2017 from the manufacturer's representative (rep).It was reported that the dye study was being performed on that day to "rule out the catheter" as a potential source of the problem.The believed that there "may be a uti that wasn't detected" before that was contributing.The patient's dose was increased to 339.8 mcg/day and it was planned that the dose would be brought back down to 260 mcg/day.The rep later reported that the dye study was being performed due to concern that the catheter might not be in the intrathecal space, resulting in the symptoms reported.The dye study was performed out 4:30 on (b)(6) 2017.The catheter was confirmed patent, however the radiologist could not determine if the catheter was in the intrathecal space.The patient was going to have a ct scan.The hcp did not prime following the cap, and it was discussed that it would take approximately 24 hours to fill the catheter.No further complications were reported.Additional information received on (b)(6) 2017 from the hcp reported they did a catheter dye study and found the catheter to be patent.The hcp was programming a priming bolus after that procedure.The hcp indicated that the pump did not update like she thought it should have after the last call.After entering the desired programming settings for the flex program and priming bolus and then completing an update of the pump, the hcp confirmed she was able to successfully update the pump that time.The dose was reported to be 300 mcg/day.Additional information was received on 2017-jun-27 from the manufacturer's representative.It was reported that the ct scan and dye study confirmed that the catheter was in the intrathecal space.No further complications were reported.Additional information was received on 2017-jun-30 from the manufacturer's representative.It was reported again that the ct scan showed the catheter was intact and in the intrathecal space.It was also reported that the interventional radiologist did not feel comfortable programming a prime following the dye study.The catheter was primed to resolve the underdose/withdrawal symptoms.No further information was reported.Additional information was received from the patient's healthcare provider (hcp) via a manufacturer's business partner on 2017-jul-03.It was reported that the patient wanted the pump removed.The patient's pump dose had been titrated down to 42 mcg/day and the hcp was inquiring if it was safe to take out the pump at that dosage.The business partner reported to the hcp that the prescribing information did not make reference to a specific dose other than decreasing the dose slowly.The prescribing information did make reference to treatment with gaba-ergic agonist drugs by stating that the suggested treatment for intrathecal baclofen withdrawal is restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted, but treatment with gaba-ergic agonist drugs, such as oral or enteral baclofen or oral, enteral, or intravenous benzodiazepines, could be utilized to prevent fatal sequelae if therapy restoration was delayed.The business partner cautioned the hcp that oral or enteral baclofen should not be relied upon to halt the progression of intrathecal baclofen withdrawal.The hcp reported that the patient's current dosage of 42 mcg/day was less than the initial dose during the screening phase of 50 mcg/day.The hcp noted that there was no reason to keep refilling the patient's pump.No further complications were reported.Additional information was received on 2017-jul-06 from the patient's healthcare provider (hcp).It was reported that, though the work-up in the hospital was negative, it was presumed that the patient had a uti and that this was the cause of the patient's underdose/ withdrawal symptoms.The patient reportedly had frequent utis and took antibiotics at home before going to the hospital.The pump and catheter evaluation with x-rays and dye study were all negative.The hcp did not know the serial number for the physician programmer related to the prime not being performed.The hcp also clarified their statement that the pump was not updating as expected.They stated that the first time, the pump did not update, but the second time it did.The patient was instructed to take oral baclofen before coming to the er and the pump setting was increased in the er as an action to resolve the underdose/withdrawal symptoms, which were again reported to be due a presumed uti.The underdose/withdrawal symptoms had been resolved at the time of the report.No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6699255
• MDR Text Key: 79580146
• Report Number: 3004209178-2017-14534
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2017
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 49 YR