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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient receiving morphine (at an unknown concentration at 6.912 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain and other chronic intractable pain in the trunk and limbs.It was reported that the patient had the pump filled on (b)(6) 2019 and found out that the battery in her pump was going bad and was supposed to "go out" on (b)(6) 2019.It was noted that the device was alarming on (b)(6) 2019 but not the patient nor someone who was with her could hear any alarm.It was reported that the patient was very sick last night and hadn't felt well all week; she had been throwing up a lot, was jittery and felt like her skin was crawling.It was noted that she began getting sick 3-4 months ago and was given on dracentrin to stop her from throwing up.The caller stated that she wanted to the pump replaced.The caller w as provided a list of healthcare provider (hcp)'s.No further 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 healthcare provider (hcp) indicated that the pump alarm was due to normal end of life which was discussed with the patient but they did not want to have the device explanted.The cause of the pump alarm not being audible was unknown.It was reported that the cause of the patient's symptoms were probably due to withdrawal.No further complications have been reported as a result of this event.

• 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: 8695421
• MDR Text Key: 148016262
• Report Number: 3004209178-2019-11500
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Date Device Manufactured: 07/21/2012
• 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: 66 YR