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

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

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 6403674
• MDR Text Key: 69947490
• Report Number: 3004209178-2017-05569
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR