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

Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144); Dizziness (2194); Therapeutic Response, Decreased (2271)

Event Date 04/10/2018

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) regarding a patient who was receiving gablofen, 2000 mcg/ml concentration at 1361 mcg/day dose via intrathecal drug delivery pump for intractable spasticity and cerebral palsy.It was reported that on (b)(6) 2018, the patient had an abrupt onset of nausea, vomiting, dizziness and pruritis with some intermittent spasms.The patient was hospitalized and given po baclofen.The hcp checked the pump logs and no alarms were seen.The hcp stated the dose was increased and the patient's symptoms improved and was discharged from the hospital and the po baclofen was stopped.The hcp stated on (b)(6) 2018 the patient developed again abrupt onset of nausea, vomiting and dizziness.Withdrawal symptom was reported on (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

Product id (b)(4) serial# (b)(4) implanted: (b)(4) 2007 explanted: (b)(4) 2018 product type catheter information references the main component of the system.Other relevant device(s) are: product id: (b)(4) , serial #:(b)(4) , ubd: (b)(4) 2008, udi#: (b)(4)update: the previously applied device code (b)(4) is no longer applicable if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative.On (b)(4) 2018 the physician accessed the pump and found instead of 13 ml, 18 ml.The patient began to have baclofen withdrawal symptoms one week ago.The event occurred during normal use.Diagnostic testing/troubleshooting performed included having accessed the fluid reservoir.It was noted that there were no environmental/external/patient factors that may have led or contributed to the issue.The decision was made at that time to exchange the catheter as well as the pump.The pump and complete catheter were explanted and replaced on (b)(4) 2018.The hcp did not request analysis results.It was noted that the hcp was notified that the product should be returned to the manufacturer; however, the customer refused return / discarded the explanted devices.The issue was resolved at the time of the report.The patient was without injury at the time of the report.It was indicated that the pump administered baclofen with concentration 1000 mcg/ml at a dose rate of 1350.Other medications (oral, etc.) the patient was receiving at the time of the event was unable to be obtained.The patient¿s weight and medical history was indicated as having been requested but was unknown.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7512050
• MDR Text Key: 108184901
• Report Number: 3004209178-2018-10848
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Date Device Manufactured: 06/14/2013
• 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; Required Intervention
• Patient Age: 26 YR