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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667); Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Pain (1994); Shaking/Tremors (2515); Weight Changes (2607); Constipation (3274)

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2009, product type: catheter.(b)(4).

Event Description

On (b)(6) 2015 information was received from a consumer regarding a patient receiving intrathecal morphine.The patient's pain had been "jacked way up" since the morning on (b)(6) 2015.They were having the shakes, and their pain was increased since (b)(6) 2015.They had diarrhea since (b)(6) 2015.They were currently sitting in their own feces and needed to get cleaned up.They normally had constipation.They thought they were going to have to go to the hospital.They did not think the pump was delivering the medication.The patient stated that the pump was supposed to be enclosed inside of a pocket.They had lost a lot of weight in the past three months, and their stomach had gotten bigger because of the flab.The pump had come loose since 2011.Their healthcare provider (hcp) wanted to wait until the patient was done losing weight before doing surgery.They had problems moving the clinician programmer to find the pump for refills.The patient thought their pump flipped.They were due for a refill in two more weeks.A nurse suspected that there may be an issue.Additional information was requested to determine relevant troubleshooting, diagnostics, actions, and interventions taken to resolve the event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5160448
• MDR Text Key: 28975712
• Report Number: 3004209178-2015-20965
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2013
• 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: 09/30/2015
• Date Device Manufactured: 11/16/2011
• 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: 00050 YR