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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Headache (1880); Nausea (1970); Pain (1994); Swelling (2091); Dizziness (2194); Complaint, Ill-Defined (2331); Malaise (2359); Abdominal Distention (2601)
Event Date 03/12/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 morphine and another unknown medication via an implanted pump. The indication for pump use was non-malignant pain. On (b)(6) 2017 it was reported that the day prior the patient started having an increase in pain. Her symptoms had come on suddenly. She started having pain in the stomach and her stomach area became bloated. After sitting down for an hour, she stood up and her legs began to swell. The left leg was more swollen than the right leg. The patient went home and took a water pill, but the pain in her stomach did not go away. The patient felt nauseated, sick, and dizzy with a headache. She was in excruciating pain and could tell the pump was not working. She took pain meds with her lyrica. The water retention had gone down some, but the pain was excruciatingly worse. The patient had no fall or trauma, but noted that she had been going to the gym and doing the treadmill and leg presses. No further patient 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)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6403674
MDR Text Key102253525
Report Number3004209178-2017-05569
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
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2017
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 Received03/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2015
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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