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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Protective Measures Problem (3015)

Patient Problems Pain (1994); Tachycardia (2095); Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

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 professional (hcp) regarding a patient who was receiving hydromorphone, 20 mg/ml concentration, clonidine, 300 mcg/ml concentration and bupivacaine, 20 mg/ml concentration at minimum rate dose via intrathecal drug delivery pump for failed back surgery syndrome and spinal pain.It was reported that empty pump reservoir occurred.The patient had a lot of other health issues and could not remember a lot.At one point, the hcp thought it might have been related to the pump/therapy however now he believed it was unrelated.The hcp had recommended the patient to be seen by a hcp for their other health issues however the patient had refused.He knew the pump was nearing end of service (eos) and he would not replace/manage the pump unless the patient was seen for their other health issues.The patient came in on monday ((b)(6) 2019) and he had interrogated the pump and the logs showed the pump was empty and was in min rate.The patient did not have any withdrawal and did not recall hearing the pump alarm.The hcp did not put the pump into min rate.Patient was being non-compliant and so he did not want to refill the pump or manage it and he was looking at having the pump permanently shut off.Since the patient was non-compliant he was going to permanently shut off the pump today.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).It was reported that the patient was here by herself for an appointment that was scheduled on monday, (b)(6) 2019, to turn off her intrathecal infusion pump.This was consistent with the ongoing pattern that the hcp had with her not being able to keep appointments, in part because of her dependence upon her husband for transportation and his unwillingness to be available when needed for her well-being.By this, the hcp was referring to the fact that the hcp saw the patient on (b)(6) 2019 and informed him that the hcp needed to increase the pace to that time.The hcp was unwilling to replace the pump given the history elaborated on previously in these medical records and briefly summarized as followed.The patient had frequent falls, frequent visits to the emergency room and shown other signs of disorientation.She had also been seeking to have fairly high doses of drugs for conditions that the pump ought to be covering such as knee and hip and low back pain.When the hcp had explained this to her in the past, she always insisted that the pump was not placed for back or knee pain, but for migraine headaches.However, the catheter tip was at around t8-t9, so it would not be expected to be effective therapy for migraine headaches.Consequently, after reviewing the data, the hcp was particularly concerned because after her appointment on monday, booth she and her husband could not recall hearing the pump go off, not in the way of alarms, nor were they aware of any withdrawal symptoms being experienced.However, when the hcp questioned her more carefully today, she indicated that at the time the hcp would expect the pump to have been completely emptied in terms of the reservoir drug, she had symptoms that she thought were withdrawals.She described the tachycardia, the feeling of anxiety, the increase in pain, and other symptoms.When the hcp calculated how much time she should have had, she could not have had more than 28 days from the time the hcp saw her on the (b)(6) until the hcp actually saw her 35 days later.On analysis, the pump indicated that she had been without therapy prior to the appointment on monday.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: 8457877
• MDR Text Key: 140122506
• Report Number: 3004209178-2019-06182
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Date Device Manufactured: 01/13/2012
• 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: 65 YR
• Patient Weight: 59