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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Nausea (1970); Overdose (1988); Vomiting (2144); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving an unknown intrathecal medication via the implanted pump for spinal pain and post lumbar laminectomy syndrome.The nurse was calling from the hospital reporting they needed the pain pump stopped.The patient was given narcan and they did a rapid airway management procedure on the patient.Following narcan the patient did start to be more responsive and was opening her eyes.It was reported the patient was admitted a couple days ago due to the patient being ¿out of it,¿ falling a lot, nausea, and vomiting.The morning of this report the patient¿s po2 sats were 86% and the patient was not responding well.The reporter was to follow up with the healthcare provider (hcp).It was suggested the hcp follow up with the pump managing physician to see if there were any recent drug refill or therapy.The emergency procedure for morphine overdose was faxed and magnet use was reviewed.The hcp reported she thought someone may have come to decrease the rate yesterday or on the date of this report, but she was unsure.The event date (b)(6) 2018.It was reviewed the patient had nausea and vomiting on the weekend, was admitted a couple of days ago, was falling down, pulse oximeter showed 86%, the patient was not responding, the pump was decreased yesterday, and the patient had a positive response to narcan and was responding/opening.No further complications were reported/anticipated or expected.

• 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): 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 Key: 7327149
• MDR Text Key: 101990560
• Report Number: 3004209178-2018-04749
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2018
• Date Device Manufactured: 08/11/2011
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR