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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problems Erythema (1840); Itching Sensation (1943); Muscular Rigidity (1968); Rash (2033); Therapeutic Effects, Unexpected (2099); Twitching (2172); Therapeutic Response, Decreased (2271); Irritability (2421)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.

Event Description

Information was received on 2016-dec-05 from a healthcare professional (hcp) via a manufacturer¿s representative regarding a patient who was receiving lioresal at an unknown concentration and dose via an implantable pump for intractable spasticity and other spasticity.It was reported that they were checking catheter to determine patency and confirm it was ¿working ok.¿ environmental/external/patient factors that may have led or contributed to the issue were unknown.The hcp wanted catheter patency checked.A patient x-ray of the pump with the connector being evaluated was an action taken to resolve the issue.At the time of the report it was unknown if the issue was resolved and the patient status was ¿alive ¿ no injury.¿ surgical intervention did not occur and it was unknown if surgical intervention was planned.Further information was received as the representative had some x-ray images of an old style pump connector and was wanting to send this image to consult.It was noted the image appeared to be of a 40 degree pump connector.Additional information was received from an hcp on (b)(6) 2016.It was reported that the patient was relatively new to the hcp.It was noted that on (b)(6) 2016 the patient had a volume discrepancy where the expected residual volume (erv) was 2.2 ml and the actual residual volume (arv) was 5 ml and the patient¿s family stated the patient had increased spasticity.The previous hcp that was managing the patient at that time attempted to do a catheter access port (cap) dye study and was unable to aspirate and gave the patient a 75 mcg bolus and the patient had no response.The hcp recently saw the patient on (b)(6) 2016 and plans were to do a pump revision.At that visit the hcp decided to decrease the dose from 1425 mcg/day to 900 mcg/day.The hcp then got a call hours later stating the patient was going through withdrawal (red, itchy, blotchy, twitching, and irritable).The hcp prescribed the patient with oral baclofen 180 mg and oral benadryl.The hcp was going to the patient¿s home (b)(6) 2016 and was going to increase the intrathecal do se and going to decrease the alarm volume to buy more time for the next refill.The hcp was unsure if the pump logs were checked in the past and knew he had not done that.The change in therapy/symptoms was considered to be both sudden and gradual.The hcp reported later on (b)(6) 2016 that he was now seeing the patient and had changed the alarm volume and was wanting to check the pump logs.The hcp was then able to visualize the logs and stated there were no alarmlogs.The hcp programmed an increase in the dose to 1100 mcg/day and would be seeing the patient in the near future for a refill.In this report, the reported medication in the pump was baclofen at a concentration of 2000 mcg/ml.The patient¿s medical history included cerebral palsy.

Event Description

Additional information was reported by the healthcare provider (hcp) on (b)(6) 2017.It was reported that the cause of the volume discrepancy and inability to aspirate was not known.It was noted that the cause would be discovered at the pump removal and replacement that was scheduled for (b)(6) 2017.It was noted that the volume discrepancy was seen at the patient¿s last refill on (b)(6) 2016 and the procedure on (b)(6) 2016 was only a reprogramming of the rate.The actions taken to resolve the event was to use baclofen systemic per ¿gt¿ for the itchy rash and irritability, an increase was finally successful to control on dose per gt of 30 mg / 4hr (180 mg/day) pump an upward adjustment of daily itb from 877.4 mcg/day to 1099 mcg/day on (b)(6) 2016.It was noted that x-rays of the pump and tubing showed everything intact on (b)(6) 2016.It was noted that the volume discrepancy, inability to aspirate, and withdrawal symptoms were resolved but only with a refill on (b)(6) 2017 with an increase of daily itb to 1425 mcg/day plus systemic baclofen per gt until surgical replacement on (b)(6) 2017.Additional information was reported by a hcp via a company representative on (b)(6) 2017.It was noted that the pump used to deliver lioresal with a concentration of 2000 mcg/ml.On (b)(6) 2017 the hcp reported that the volume discrepancies were not ¿clarified¿ at the replacement procedure.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative on (b)(6) 2017.On (b)(6) 2017, a nurse practitioner (np) refilled the patient¿s pump and stated that the expected residual volume was 5.1 ml; however 7 ml was actually aspirated.It was further stated that the same trend occurred prior to his pump replacement.Environmental/external/patient factors that may have led or contributed to the issue was noted as being unknown.No diagnostics / troubleshooting were performed.No actions or interventions were taken; no surgical intervention was planned.It was unknown if the issue was resolved at the time of the report.The pump was administering lioresal.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.Regarding the pump replacement on (b)(6) 2017, the pump was returned to the manufacturer and as per the pump¿s log, baclofen with concentration 2,000.0 mcg/ml was being administered via a simple continuous dose rate of 1,582.4 mcg/day as of (b)(6) 2017.The patient was without injury regarding their status at the time of the report.A company representative reported that additional information was planned to be obtained from the hcp on (b)(6) 2017.On (b)(6) 2017 a company representative further reported that they were not yet able to obtain additional information from the hcp.The company representative further indicated there were no known patient symptoms related to the reported volume discrepancy found during the pump refill performed on (b)(6) 2017.It was unknown if any troubleshooting / diagnostic tests were performed related to the volume discrepancy that occurred on (b)(6) 2017.The cause of the volume discrepancy on (b)(6) 2017 was unknown.Regarding if the volume discrepancy that occurred on (b)(6) 2017 resolved, it was noted that a pump refill was performed.

Manufacturer Narrative

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.

Event Description

Additional information was received from the representative on 2017-mar-21.It was reported that the hcp didn't leave the correct printout and to their knowledge the patient was doing well.

Manufacturer Narrative

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6223111
• MDR Text Key: 63874626
• Report Number: 3004209178-2017-00214
• Device Sequence Number: 1
• Product Code: LKK
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 03/20/2017
• Supplement Dates FDA Received: 02/07/2017; 03/07/2017; 03/22/2017; 09/28/2017
• Date Device Manufactured: 06/08/2011
• 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): Required Intervention
• Patient Age: 15 YR