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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key8457877
MDR Text Key140122506
Report Number3004209178-2019-06182
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/13/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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