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 Hypoventilation (1916); Overdose (1988); Sedation (2368); Cognitive Changes (2551); Lethargy (2560)

Event Date 02/14/2017

Event Type  Injury  

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 healthcare provider (hcp) regarding a patient who was receiving fentanyl at an unknown concentration via an implantable pump.On 2017-feb-27, it was reported that the patient was in the icu due to an altered mental status.It was reported that the patient could not be aroused.Narcan had been provided, but had not made a difference.The patient had been put on a ventilator.The hcp wanted to set the pump to the lowest setting to see if the patient's fentanyl was causing the patient's symptoms.It was also reported that the patient was falling which was secondary to delirium tremens, which began on (b)(6) 2017.It was reported that the patient required an mri.No additional complications were reported.

Manufacturer Narrative

(b)(4).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

Additional information was received from the patient's healthcare provider (hcp) on 2017-apr-11.It was reported that the patient passed away at another hospital for events unrelated to his intrathecal drug delivery device.Additional information was received from the healthcare provider (hcp) on 2017-apr-28.It was reported that the patient experienced hypoventilation due to narcotics and sedation and that this was the cause for the patient's admission to the icu in february.The hcp indicated that the pump was reset to the lowest level by a manufacturer's representative and that by (b)(6) 2017 the patient began to arouse.The hcp also noted that the patient was receiving opiates from multiple providers and had alcohol that the patient's family wasn't aware of.According to the hcp, "if all [the patient] had was the pump, [they] would not have experienced those symptoms." the pump was considered a contributing factor, but no malfunction was suspected in relation to the patient's symptoms and the dosage was lowered to take the variable out of the equation.

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): 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: 6420341
• MDR Text Key: 70425325
• Report Number: 3004209178-2017-05997
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Date Device Manufactured: 07/19/2011
• 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): Life Threatening
• Patient Age: 74 YR