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

Model Number 8637-40

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

Patient Problem Pain (1994)

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 healthcare professional (hcp) manufacturer representative (rep) regarding a patient who was receiving morphine, 20 mg/ml concentration at 2.246 mg/day dose via intrathecal drug delivery pump for non-malignant pain.It was reported that patient called the healthcare professional (hcp)'s office to inform office staff that her pump had started alarming on monday, (b)(6)`.She had also noticed her pain had started increasing.Patient may have reached its elective replacement indicator (eri).At patient's last refill in (b)(6) 2017, estimated eri was 6 months.Patient was due for a pump refill in (b)(6), but the hcp's office had called her before her refill appointment to inform her that the hcp was dropped and it was effective (b)(6) 2018.She would need to either find a new provider or change her insurance that covered appointments at the office.Patient was provided the names of the insurances that cover visits with the hcp.Drug in pump was over 6 months old.Diagnostics/troubleshooting that was performed was unknown.Patient was instructed to call the hospital to get the names of providers she could see for her pump refills and pump replacement.At the time of this report, the issue was not resolved and patient status was alive-no injury.Surgical intervention did not occur and it was unknown if it was planned.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from healthcare professional (hcp) via manufacturer representative (rep).It was reported that the rep had not been able to see the patient to determine if the alarm was an elective replacement indicator (eri) alarm.Patient had not established a new pump managing hcp.The hcp stated patient had called the office to get the names of insurances contracted with the hcp but she had not heard from patient since.No further complications were reported.

• 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: 7518217
• MDR Text Key: 108499947
• Report Number: 3004209178-2018-11022
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Date Device Manufactured: 06/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR