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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Mechanical Jam (2983)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was provided by a healthcare provider regarding an implantable intrathecal pump intended to deliver morphine [25 mg/ml] at 10 mg/day, indicated for spinal pain.It was reported that an active motor stall was seen at initial interrogation on (b)(6) 2018.The patient was unable to receive a patient-activated bolus dose and an 8476 cod was confirmed via their personal therapy manager (ptm).It was stated that there had been multiple motor stalls.It was confirmed via the event logs that a motor stall occurred on (b)(6) 2018 at 19:39, with a recovery on (b)(6) 2018 at 06:50.Another stall occurred on (b)(6) 2018 at 02:04 with no recovery to date.It was stated that the patient had not recently had an mri (magnetic resonance imaging), nor did they have an mri on the dates of (b)(6) 2018.No medical symptoms were reported.Additional information was received from a healthcare provider (hcp) via a manufacturer's representative on 201-jul-12.The hcp reported multiple motor stalls/recoveries since (b)(6) 2018.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.It was unknown what diagnostics/troubleshooting were performed.As an action/intervention to resolve the issue, a replacement surgery was scheduled for (b)(6) 2018.The issue was not considered resolved at the time of the report.Surgical intervention was scheduled, but had not yet occurred.A the time of the report, the patient's status was listed as ¿alive ¿ no injury.¿ the patient¿s medical history and weight were asked but unknown.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the pump on 2018-aug-29 revealed a pump motor gear train anomaly regarding corrosion and/or wear and/or lubrication; stall was due to the shaft-bearing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer's representative on 2018-jul-16.It was reported that the pump was replaced.The pump segment of the catheter was prophylactically replaced during the procedure with a new pump segment.The pump was delivering infumorph 25 mg/ml at 10.99 mg/day.The patient's relevant medical history was unknown.The patient stated that he had mri's on (b)(6) 2018 and on (b)(6) 2018, and there was no issue with a motor stall at that time.The logs read on (b)(6) 2018 started on (b)(6) 2018, and showed the last motor stall on (b)(6) 2018 at 12:10 and a recovery on (b)(6) 2018 at 05:32.The explanted pump was sent to pathology per account protocol, and was to be returned to the manufacturer when available.

• 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: 7687363
• MDR Text Key: 114009521
• Report Number: 3004209178-2018-15751
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 86