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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 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abnormal Blood Gases (1034); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Shock (2072); Cognitive Changes (2551); No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2018
Event Type  Injury  
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from an hcp. It was reported that a manufacturer clinical specialist reduced the pump by about 20%. A computed tomography (ct) scan of the patient's abdomen and pelvis was performed and demonstrated a normal placement of the pump with no obvious anatomic malfunction. The patient had expired on 2018 (b)(6). The hcp also reported that the patient's symptoms appeared to be more similar to baclofen withdrawal and they were not sure if an overdose had occurred. There was no evidence of seizure. The pump was confirmed to not be malfunctioning. According to the hcp, the patient's narcan drip was initiated because the admitting physician did not know how to stop the pump. The drip was on hold after the pump was adjusted. There were no further complications reported.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient receiving unknown baclofen and unknown morphine, both of an unknown concentration and dose via an implantable infusion pump for intractable spasticity and other spasticity. It was reported that the patient had overdose symptoms and a narcan drip was administered with continuous infusion beginning at 13:02 today. It was currently 14:43 and the patient was currently in the intensive care unit (icu). The patient had a morphine pain pump and they did not know how to stop the pump as they knew nothing about the pump. It was thought that the patient's pump follow-up doctor traveled 200 miles to install the pumps. The reporting hcp had tried contacting the doctor for other pump patients and the doctor/clinic never contacted them back. The patient presented to the emergency department (ed) today at 06:22 with altered mental status, severe lactic acidemia and severe hypotension along with shortness of breath and shock. The patient was not responding to her husband since earlier this morning. The hcp was not certain if the pump was alarming or not. No further complications were expected or anticipated. The patient's medical history included having astrocytoma at t4 since 1985 and was paraplegic from t5 down.
 
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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 Key7209987
MDR Text Key103552185
Report Number3004209178-2018-01113
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 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received01/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/10/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2018 Patient Sequence Number: 1
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