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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Nausea (1970); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving morphine (unknown dose and concentration) via an implantable pump for spinal pain.The rep called in to report they were contacted by the hcp and notified that the patient had been reporting since (b)(6) 2017 that they had been feeling as though they were not getting efficacy anymore.The rep stated that the patient felt flu-like symptoms but the patient did have the flu twice between (b)(6) 2017 and present time so that made it confusing for the hcp to diagnose the issue.The rep reported that the patient was refilled in (b)(6) 2018 and a volume discrepancy was identified (arv less than erv).The actual reservoir volume (arv) was 0 ml, and the expected reservoir volume (erv) was 3.7 ml.The pump was refilled and after the refill, the patient reported feeling nauseous and shortness of breath for about 48 hours.The rep was not aware of any difficulties with refilling the pump.The rep was encouraged to evaluate for other possible causes.The rep stated that the hcp was scheduling diagnostics for the system and stated that the hcp mentioned a dye study and rotor study.The rep stated that the hcp would text the rep once the appointment was scheduled.Additional information provided stated that the hcp reported that the patient was "kooky".The rep stated that the patient was fine at the last refill and had no issues or questions, but when the patient came into the office today ((b)(6) 2018), they were angry and demanding to know why the pump was empty.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7651881
• MDR Text Key: 112859362
• Report Number: 3004209178-2018-14705
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 06/29/2018
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Age: 63 YR