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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

Patient Problems Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving 2000 mcg/ml of gablofen via an implantable pump.The indication for use was not provided.It was reported the patient¿s pump was empty.The empty reservoir had occurred.It was reported the patient was normally refilled every four to five months and the last refill was on (b)(6) 2018.The hcp used to refill the patient¿s pump more frequently but now they wait the four to five months because they know the drug is stable for 180 days.The patient¿s intrathecal dose had been increased from 159.9ug/day to 300ug/day (gablofen at 2000 mcg/ml) while the patient was in the hospital.However, the clinic was never notified of that change.Therefore, the empty reservoir occurred unexpectedly.The patient was asymptomatic with no changes to their therapy.Telemetry was performed (b)(6) 2018.The expected residual volume was 0 milliliters (mls) and actual residual volume was 0.5 mls.Per the event logs, the empty reservoir occurred on (b)(6) 2018.The hcp inquired about acceptable levels and what the next steps should be for the patient.Technical services reviewed the pertinent information per the hcp¿s inquiries.The hcp planned to confer with the doctor.Empty pump considerations were reviewed: reviewed why no priming was needed, reviewed dosing considerations, reviewed refilling and monitoring for volume discrepancy and efficacy, reviewed consideration for catheter tubing patency/damage.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

Patient code (b)(4) is no longer applicable.If information is provided in the future, a supplemental report will be issued.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 the healthcare provider (hcp).It was indicated the patient's dose was not increased while they were in the hospital, it was increased when the patient was in the office.This occurred on (b)(6) 2018.The pump was increased due to increased spasticity; therefore, the decision was made to increase the pump settings.The hcp stated the patient did not have/exhibit any symptoms related to the empty pump.The pump was refilled uneventfully, and the issue had been resolved.

• 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: 7573485
• MDR Text Key: 110463149
• Report Number: 3004209178-2018-12713
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Date Device Manufactured: 09/14/2012
• 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 Age: 15 YR
• Patient Weight: 35