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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Muscle Weakness (1967); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Sedation (2368)

Event Date 07/27/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 220 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.On (b)(6) 2019 it was reported that 24 days after the patient¿s pump was replaced on (b)(6) 2019 the patient started having withdrawal symptoms.The patient got itchy and started having return of spasticity.The patient had to be hospitalized for a while (dates unknown by reporter).The physician did a cap (catheter access port) aspiration successfully and it was noted that the catheter was not touched during the pump replacement procedure.The physician changed the daily dose from 220 mcg/day to 400 mcg/day and was giving the patient oral medication and that seemed to control the situation.The physician saw the patient yesterday ((b)(6) 2019) for a refill and right after he filled the pump, the patient went super loose like an overdose.The physician reduced the dose to 220 and monitored the patient.The physician confirmed the drug concentration with the surgeon.The patient¿s change in therapy/symptoms was a sudden change.No further complications have been reported as a result of this event.

Event Description

Additional information was received on 08-oct-2019 from a healthcare professional (hcp) who reported that the cause for the patient¿s withdrawal symptoms 24 days after the pump replacement procedure on (b)(6) 2019 and the cause for the patient getting super loose after the pump refill procedure was not determined.Per the hcp, the patient was seen on (b)(6) 2019 after the pump replacement procedure at which time her spasticity remained well controlled.She was subsequently admitted to the hospital on (b)(6) 2019 withsymptoms of itching and increased spasticity.She reported that the symptoms were present for 1 day.She was diagnosed with a urinary tract infection and her spasticity symptoms did improve with iv (intravenous) antibiotics, but then subsequently worsened.Her intrathecal pump system was evaluated during her admission for possible malfunction which included assessment of programming, x-rays, and side port access.The evaluation suggested normal function.Her intrathecal baclofen dose was incrementally increased (230 mcg/day prior to pump replacement to 400 mcg/day), but there had been no significant change of her spasticity symptoms.She was then seen in the clinic on (b)(6) 2019 (not (b)(6) 2019 as previously reported) for her first pump refill following the pump replacement procedure.There was an expected amount or residual intrathecal baclofen in the pump that was withdrawn and discarded prior to refilling the pump.A dose increase was not programmed.It was noted ¿concern regarding a dose increase is the possibility that a lower concentration of intrathecal baclofen was filled at the time of pump replacement than request.This would result in a sudden shift from underdosing to overdosing at time of refill.However, the time course of patient¿s increased spasticity symptoms does not suggest that an incorrect concentration of intrathecal baclofen was filled at the time of pump replacement.Prior documentation indicates that the pump was filled with the requested/correct concentration (2000 mcg/ml).¿ the patient¿s husband contacted the clinic 1 day after her refill appointment to report excessive looseness and sedation.The looseness and sedation started within a few hours of her pump refill.It was noted, ¿again, the time course does not suggest an incorrect concentration of medication, as it would take 1 to 2 days for the increased concentration of the intrathecal baclofen that was just refilled in the pump to reach the end ofthe catheter¿.They were instructed to be seen at the clinic and her intrathecal baclofen dose was decreased from 400 mcg/day, in flex programming, which included 75 mcg bolus doses at 04:00, 10:00, 16:00, and 20:00 to 250 mcg/day, flex programming, which included a 75 mcg bolus doses at 04:00, 10:00, 16:00, and 20:00.While the looseness and sedation reduced, she continued to feel that the dose was excessive.On (b)(6) 2019 the pump dose was decreased again from 250 mcg/day in flex programming to 220 mcg/day, flex programming, with no change to the 25 mcg bolus doses at 04:00, 10:00, 16:00, and 20:00.The patient was to continue oral baclofen 10-20 mg 4x/day as needed.There was a plan for ct study for any complications or concerns moving forward, but at this time the intrathe cal baclofen pump system appeared to be functioning correctly, so a contrast study would not provide any value that the hcp could think of.The patient was to return to the clinic as needed and/or 2 weeks prior to the low reservoir alarm date in march.It was noted that, ¿the patient¿s recent response to intrathecal baclofen is consistent with underdosing prior to refill followed by overdosing after refill, even though no change was made to the concentration or dose¿.Per the hcp, they were unable to identify an obvious cause for the patient¿s symptoms.The device remained implanted.The patient¿s medical history included spasticity secondary to multiple sclerosis, anxiety, depression, dvt (deep venous thrombosis), leg swelling, mobility impaired, neurogenic bladder, overactive bladder, urinary incontinence, social drinker, and medical marijuana use.The patient¿s surgical history included baclofen pump implant, cesarean section, and baclofen pump replacement.The patient¿s allergens included levaquin (hives and colitis), codeine (nausea only), and penicillins (rash and diarrhea).The patient¿s concomitant medications included acetaminophen, alemtuzumab, oral baclofen, cholecalciferol/vitamin d3, diazepam, escitalopram, melatonin, modafinil, triamcinolone, trimethoprim, and warfarin.No further complications have been reported as a result of this event.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9155880
• MDR Text Key: 162976117
• Report Number: 3004209178-2019-18992
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 69