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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 Problems Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)
Patient Problem Underdose (2542)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event is an estimate. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving dilaudid (10. 0 mg/ml, 0. 480 mg/day) via intrathecal drug delivery pump for non-malignant pain. It was reported that the patient's pump was not working properly. In (b)(6) 2018 the patient went to the emergency room because she was not getting enough medication; the doctor increased the drug by 5%. On (b)(6) 2018 a manufacturer representative (rep) met with the patient and did a dye test, and everything was ok. The drug flow was not checked. When she got a refill on (b)(6) 2018 the doctor said there was more drug in the pump than usual. When the patient called the doctor's office to see what the next step was, she was told the doctor was busy with procedures. She wanted to talk to a rep. No further complications were reported.
 
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 did not and 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 the healthcare professional. It was reported that the pump not working properly referred to more medicine than expected in the pump. The actual residual volume was 38 ml and the expected was 34 ml. They were unable to determine the cause of the volume discrepancy and were concerned the patient was not getting the correct dose. They put the correct volume in and entered it into the "interrogator" (thought to refer to the clinician programmer) to resolve the volume discrepancy. The volume discrepancy was not resolved to date. The patient's weight was (b)(6). 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 Key7534986
MDR Text Key108986670
Report Number3004209178-2018-11566
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/27/2012
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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