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

Model Number 8637-40

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8870, serial # unknown, product type: software.Other relevant device(s) are: product id: 8870, serial/lot # unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via company representative (rep) regarding a patient receiving lioresal 4000 mcg/ml at 435.4 mcg/day in flex mode via an implanted pump for intractable spasticity.It was reported the office was experiencing some unique issues with the 8840 with the reservoir volume.There appeared to be an erroneous low and empty reservoir alarm that was showing under current pump settings.It was noted this was most likely caused by an old software card in the 8840.The rep believed that they use aau and this was confirmed by the caller via email after speaking with the hcp.The issue was resolved by having the hcp change the volume to a different volume and update and then back to the volume they actually want and update.The erroneous alarm cleared, and patient symptoms were not reported.The event date was (b)(6) 2018.It was further reported the rep was not with the hcp at the time of the call so did not know step by step what they did to have this erroneous low and empty alarms occur.The pump logs provided last change (b)(6) 2018 showed the reservoir volume was 20ml (0 mls dispensed since update) and the low reservoir alarm date was (b)(6) 2018 and the empty reservoir alarm occurred.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Concomitant medical products: product id 8840, serial# unknown, product type programmer, physician is also applicable to this event.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
• MDR Report Key: 7903172
• MDR Text Key: 122332163
• Report Number: 3004209178-2018-21397
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR