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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2017

Event Type  Injury  

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

Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was receiving a concentrate on of 2000 mcg baclofen at a dose of 723 mcg and a concentration of 2.0 mg marcaine at a dose of 1.7 mg via an implantable pump for intractable spasticity.It was reported that the patient had an mri on the cervical, thoracic, and lumbar spine.Then they went to check the pump after the mri and the motor stall did not recover.It was noted they tried multiple programmers.The mri may have led or contributed to the issue.They waited 1 hour after the mri, changed the alarm date volume from 1 mg to 2 mg and hit update; re-read the pump with no change; changed the clock on the pump, updated and re-read the pump with no change; then came back to read the pump 3 hours later and the pump still said "motor stall occurred" with no recovery.The patient was turned to minimum rate and was being monitored in the hospital.They were planning on replacing the pump, however it was not scheduled at this time.The event was unresolved and the patient was noted to be "alive - no injury".It was later reported that the patient had an mri on (b)(6) 2017 and when checked after mri, the system had returned to normal operating mode.The patient had another mri the next day and when read afterwards, the pump did not recover.It was further stated that the pump never recovered.The patient had no symptoms.It was noted the device was implanted in 2012 and the doctor had been working on getting the pump replaced.At the time, replacement had not been scheduled.No further complications were reported or anticipated.

• 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: 6846764
• MDR Text Key: 85090984
• Report Number: 3004209178-2017-18861
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2017
• Date Device Manufactured: 09/08/2012
• 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-0592-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR