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

Model Number 8637-40

Device Problems Premature End-of-Life Indicator (1480); Battery Problem (2885)

Patient Problems Nausea (1970); Therapeutic Response, Decreased (2271); Sweating (2444); Shaking/Tremors (2515); Alteration In Body Temperature (2682)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

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 fentanyl (2000 mcg/ml at 900 mcg/day) via an implantable infusion pump. The indication for use was non-malignant pain. It was reported that the patient went to the emergency room because her pump was emitting a critical alarm and she was experiencing stomach problems, "was hot and cold at the same time", profusely sweating and feeling shaky. A device manufacturer representative came to the emergency room and tried to get the pump to start again but said that the pump had died early; the pump battery was expected to last until august. It was reported that the representative turned the pump alarm off and "lowered it to the lowest possible setting". The patient was prescribed fentanyl patches on her back to help with withdrawal by the managing healthcare provider (hcp). The patient was concerned because on (b)(6) 2017 she started hearing the critical alarm again, this was explained to the patient to be due to the reported low or depleted battery. The patients symptoms were reported as a sudden change. The caller was redirected to follow up with the hcp. No further 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.

Event Description

Additional information was received from a consumer indicated that the pump had been alarming every 10 minutes. It was reported that the healthcare provider (hcp) was gone for over a week and the caller requested to have a device manufacturer representative contacted to stop the patients pump alarm. No further complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4). 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: 7440398
• MDR Text Key: 105884954
• Report Number: 3004209178-2018-08312
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• 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 Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/14/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial