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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 10/13/2018

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 patient via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device.The drugs being delivered were bupivacaine and morphine at a dose of 5 mg/day with unknown concentrations.The reason for use was non-malignant name and failed back surgery syndrome.It was reported that the patient presented to the clinic on (b)(6) 2018.Interrogation of the device was performed and a motor stall was seen.It was unknown if the patient recently had an mri.The caller reported multiple motor stalls and recoveries per the event logs beginning (b)(6) 2018 with the last stall occurring on (b)(6) 2018.Running the logs showed 3 separate motor stalls and the third was without recovery.Over the course of the weekend the patient went through withdrawal and was presented to the emergency department.A consult was scheduled with the neurosurgery department for replacement and surgical intervention was planned.It was unknown if surgical intervention did occur.Environmental/external/patient factors that may have led or contributed to the issue included a compounded drug being used.Troubleshooting with the caller consisted of reviewing pertinent information per their inquires including that the patient¿s pump was not affected by the battery fca (field corrective action).The rep had to leave the phone conversation as the doctor was requiring assistance from them.The issue was not resolved at the time of the report, and the patient status was listed as ¿alive ¿ no injury.¿ there were no further complications reported/anticipated.

Manufacturer Narrative

Logs indicate that the drugs being delivered were 20 mg/ml morphine at 0.126 mg/day and 20 mg/ml bupivacaine at 0.126 mg/day.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp) via rep on 2019-apr-03.The device had been replaced on (b)(6) 2018 due to ¿motor stall ¿ early eri (elective replacement indicator).¿ the product was returned to the manufacturer for analysis.The patient was not in a clinical study and there was no patient death.There were no further complications reported/anticipated.

Manufacturer Narrative

Analysis found there was corrosion/wear/lubrication on the gear train of the pump motor and that there was a stall due to shaft bearing.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7990846
• MDR Text Key: 124548836
• Report Number: 3004209178-2018-23566
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR