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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Data Problem (3196)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8870, serial#: unknown, product type: software.Product id: a810, serial#: not applicable, product type: software.Other relevant device(s) are: product id: 8870, serial/lot #: unknown.Product id: a810, serial/lot #: not applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving hydromorphone (20 mg/ml at 4.3 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain and failed back surgery syndrome.It was reported that since (b)(6) 2017 the pump reports have been displaying "eri occurred, schedule to replace by".It was noted that there were no audible alarms and no volume discrepancies.The caller stated that they would likely schedule a replacement soon but it was not yet scheduled.No symptoms were reported.No further complications have been reported as a result of this event.On (b)(6) 2019 crts update and images x2, e1 (rep): pump logs were received.8840 logs indicated a "eri occurred, schedule to replace pump by ??/??/????" message and tablet logs indicated "pump has reached the elective replacement indicator (eri).To prevent loss of therapy, schedule to replace the pump by -----.".

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative (rep) on 2019-may-21.It was reported that the 8840 that was submitted was generated by an 8840 belonging to the clinic, one of 10 to 15 that have been assigned to the clinic.The report was generated in the clinic's system back in 2017.The serial number of the 8840 and the software version number and serial number for the 8870 were unknown.No further complications were reported.

Manufacturer Narrative

Additional review/investigation indicates c91397 does not apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Logs also indicated a note that there was an issue with the value from the pump memory which was software related, and a telemetry uplink problem was noted.

• 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: 8624152
• MDR Text Key: 145748436
• Report Number: 3004209178-2019-09901
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• 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: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 103