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 Pain (1994); Therapeutic Response, Decreased (2271); Cognitive Changes (2551)

Event Date 07/19/2017

Event Type  Injury  

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for malignant pain.The pump contained an unknown brand of morphine [20 mg/ml] at a dose of 18 mg/day and bupivacaine [10 mg/ml] at a dose of 9 mg/day.It was reported a motor stall was seen at initial interrogation.The patient did not recently have an mri.The representative stated the patient developed altered mental status a couple days ago and had been hospitalized.The representative stated the pump was interrogated, and there was a motor stall.The representative did not have access to the pump logs at that time.The representative denied electromagnetic interference (emi) or magnetic interaction.The representative would check the pump status again and obtain the pump logs.The change in therapy/symptoms was considered sudden.The altered mental status started ¿a couple days ago¿.An hcp called about the patient that same day.The hcp stated the motor stall occurred (b)(6) 2017 at 04:16 am and tube set occurred (b)(6) 2017 at 04:16 am.The hcp stated the patient told her he was in an mri suite around that time.The hcp stated she would recheck the pump status with the logs.No further patient complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the hcp reported the pump was explanted.The symptoms were resolved by changing the patient to oral medication.The hcp was not sure if the pump would be returned to the manufacturer for analysis.The ¿operating room (or)¿ people were supposed to send it back.

Manufacturer Narrative

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

Event Description

Additional information received from consumer on 2018-jan-09 reported there was a pump failure and delivery failure that were under investigation.The patient had injuries of pain, withdrawal, and surgery which were under investigation.The date of injury was noted as (b)(6) 2017, which was under investigation.It was noted that the pump was explanted in (b)(6) 2017.No further complications were reported.

• 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: 6735957
• MDR Text Key: 80801118
• Report Number: 3004209178-2017-15382
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Date Device Manufactured: 10/23/2012
• 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; Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 97