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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 Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Swelling (2091); Malaise (2359)
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving morphine 10mg/ml at 1. 79mg/day via an implantable pump. The indications for use were non-malignant pain and failed back syndrome-other. The patient reported that he thinks his pump stopped over a month ago and the patient had been having problems ever since. The patient stated he was swollen up and was having shortness of breath. The patient was physically fit and had never had this problem before. The patient couldn¿t exercise. The patient stated he didn¿t think the pump had been working and wanted to have it removed. The patient¿s physician was not available until (b)(6). The patient planned to follow up with their healthcare provider. No further complications were reported.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer. The patient was receiving morphine(1. 6 mg/day) at unknown concentration and clonidine at unknown concentration and dosage. It was reported that the patient had been sick the last three months. The pump started beeping in (b)(6) and his roommate noticed the beeping. The patient did not notice the alarm since he had constant ringing in his ear which was unrelated to device or therapy. At first, the alarm was thought to be from the phone. The patient said that it was a single tone which switched over to a dual tone and the it was unknown when the tone switched. The beep was real faint at the time of the report. It was stated that he was out of breath. On (b)(6) 2018, the patient got filled up and the healthcare provider (hcp) withdrew out twice as much liquid as supposed to have in the pump and therefore the patient knew the pump hadn't been working. The patient had been in and out of hospital twice in (b)(6). The patient got tired walking around the house which also started in (b)(6). The patient did not need the pump anymore. No interve ntion was mentioned. No further complication was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7513745
MDR Text Key108233341
Report Number3004209178-2018-10886
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2011
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: 05/15/2018 Patient Sequence Number: 1
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