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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 Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problems Nausea (1970); Vomiting (2144); No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2018
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 consumer regarding a patient who was receiving fentanyl and clonidine at unknown doses and concentrations via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported that the patient was weaning off medication to have the pump removed and was taking oral medication. The pump alarm had been going off every 10 minutes because she no longer had medication in the pump. The alarm started about 2 to 3 weeks ago. The patient had been working with one hcp for her pump, but did not see him anymore. The patient was trying to see a new hcp to have the pump removed. No further issues were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer. It was reported that the patient was starting to feel nauseous and was throwing up. It was stated the patient knew she was beyond the point of any withdrawal symptoms since her pump had been alarming since (b)(6) 2018. It was asked if there were any other health related concerns to having the pump in the body. No further issues were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 19-jun-2018 from the patient who reported that her medical history included a problem with her back for the last 37 years. Per the patient, her pump had been empty since the beginning of (b)(6) 2018. The patient had no withdrawals and there was no more beeping. The beeping had started ¿probably the second or third week of (b)(6) 2018¿. The patient stated that the pump was not beeping anymore because the ¿battery is dead, there is nothing in the pump anymore¿. The patient had been referred back to the physician who implanted the pump in 2011, however, she had been waiting since (b)(6) for an appointment. No further complications have been reported as a result of this event.
 
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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 Key7538961
MDR Text Key109110886
Report Number3004209178-2018-11706
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 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2012
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 Received06/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/25/2011
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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