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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Electromagnetic Interference (1194); Mechanical Jam (2983)

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

Event Date 04/05/2018

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) via a company representative regarding a patient who was receiving an baclofen with concentration 2000 mcg/ml at a dose rate of 132.1 mcg/day via an implantable pump for intractable spasticity and multiple sclerosis.It was reported that the patient recently had magnetic resonance imaging (mri) performed.The mri was not due to a suspected problem with the patient¿s device or therapy.A motor stall was seen at initial interrogation.Regarding the pump logs, the motor stall recovery message had not occurred.It was noted as having been 3+ hours since the patient had exited the mri field, but the pump had not been read post mri until about 15 minutes prior to the report (the date and time of the call report was (b)(6) 2018 03:27 pm).Reviewing telemetry state and re-interrogation the pump with logs was being considered.Interrogation did not result in a motor stall recovery as the pump was programmed in a minimum rate mode.The company representative planned to wait another 20 minutes and continue to re-interrogate for a new set of event logs until the motor stall recovery message could be confirmed.Neither the patient nor the physician had heard the audible pump alarm.No medical symptom was reported.A sudden or gradual changed in therapy or symptoms was noted as being not applicable.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the company representative april 10, 2018.Regarding actions and interventions taken, technical services had been called.No further information was available at the time.The representative was waiting to hear back from the physician.The patient's weight was unknown, and would not be available.

Manufacturer Narrative

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

Event Description

Additional information was received from the company representative april 26, 2018.The rep reported that no other actions were taken other than calling technical services.The rep stated that the alarm could not be heard and the motor stall had recovered.No additional information was 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: 7408507
• MDR Text Key: 105250473
• Report Number: 3004209178-2018-06784
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 04/26/2018
• Supplement Dates FDA Received: 04/13/2018; 04/30/2018
• Date Device Manufactured: 01/30/2012
• 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: 40 YR