MAUDE Adverse Event Report: MEDTRONIC 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 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8870, serial#: (b)(4), product type: software. Other relevant device(s) are: product id: 8870, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) regarding a patient receiving remodulin 10 mg/ml for a total dose of 4. 722 mg/day via an implantable pump. It was reported there were unexpected low and empty reservoir alarms in the logs. On (b)(6) 2020, the patient underwent a pump refill and the alarm check was completed post refill. Roughly 10 minutes after this, they heard an alarm go off. The pump was interrogated again, and all looked normal on the interrogation. Per the site, the interrogation post refill included an empty reservoir alarm occurred and a low reservoir alarm occurred both on (b)(6) 2020 at 13:45. The pump status reports were reviewed and found no reason for the critical alarm sounding after the refill on (b)(6) 2020. It was noted that a software bug was suspected as there were 8 similar events. The event will try to be replicated given the programming details. No symptoms were reported. No actions or interventions were taken. The event date was (b)(6) 2020. No further complications were reported/anticipated. (b)(6) 2020 e2 (hcp, sdy, rep): additional information was received from an hcp via a clinical study and manufacturer representative on (b)(6) 2020. It was reported that logs were checked to confirm that the reservoir volume was updated after refill. 40ml were filled into the reservoir and the cause of the issue was believed to be a software bug. The issue was explained and resolved.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10368091
• MDR Text Key: 201907810
• Report Number: 3004209178-2020-13481
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2019
• 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: 08/17/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial