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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 Pumping Stopped (1503); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6) 2017 from the patient¿s friend/family member who reported that the patient¿s pump had been malfunctioning since (b)(6) 2015. The patient had gone through a series of lowering the dosage down before shutting it off. The last refill was (b)(6) 2017, but they didn¿t empty it. They left the medication in there. The pump was shut off on (b)(6) 2017. The patient started going with withdrawal that day. Per the reporter, the patient for sure heard the alarm at 1 am today ((b)(6) 2017) but stated that it could have been earlier as the patient was going through withdrawal. Additional information was received on 01-sep-2017 from the patient who reported that the pa (physician¿s assistant) programmed the pump to minimum. The patient was going in on tuesday and wanted to make sure she understood that the pump could be turned off but that they would have to call for a code. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a patient. It was reported that patient's pump started alarming on (b)(6) 2017. The healthcare professional (hcp) didn't shut it down right. The hcp didn't call into the manufacturer to get the code to completely shut it down. The patient had been trying to find a hcp that would take the pump out. The pump started alarming on saturday night every 60 seconds for a total of 17 seconds which was a total of 26 beeps. Patient thought the battery would have died a while ago. With the beeping she was getting no sleep, she couldn't leave the house. She could hear the beeps through a t-shirt and a jacket. Patient was getting the dual tone alarm. Patient said her stomach was kind of sore. Patient said probably the last eight months or more. 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 via a company representative. It was noted that the pump alarmed and had reached end of service (eos) as expected based on implant date. Steps to turn the pump alarm off by confirming terminal event message on the programmer was reviewed. It was noted that the company representative clicked ¿yes¿ which should disable the pump alarms.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 intrathecal bupivacaine 5 mg/ml at 1. 3017 mg/day and morphine 10 mg/ml at 2. 603 mg/day via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported that the patient¿s pump was alarming. A pump study was done, and it showed a malfunction. They suggested replacing the pump. The pump was being titrated so it could be switched out. The patient¿s dose had been reduced every 2 weeks. The patient was ¿told that the pump was reduced 5% without being told. ¿ it was noted that the healthcare provider (hcp) was no longer going to see the patient, and the patient was told that she was non-compliant. The patient did not currently have a hcp at this time. The event date was noted to be (b)(6) 2015. It was also noted that the patient said she was ¿late to an appointment. ¿ there were no further complications reported.
 
Event Description
Additional information was received from a healthcare provider (hcp). It was reported that the patient¿s new managing hcp had additional questions about the patient. The hcp asked if there was a way he could obtain medical records for this patient since he was seeing that there was some history about the pump malfunctioning. The hcp would be seeing the patient in the next week or two (from (b)(6) 2017). Before then, he would contact the patient¿s previous managing hcp as well as reach out to manufacturing representatives to see if they had any additional information about this patient.
 
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key6523210
MDR Text Key101883844
Report Number3004209178-2017-09119
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
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2012
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 Received09/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/10/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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