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

Model Number 8637-20

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

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

Event Date 11/25/2017

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) via a manufacturer¿s representative (rep) regarding a drug infusion device.The drugs being delivered were 400 mcg/ml fentanyl at 46.64 mcg/day and 30 mg/ml morphine (unknown) at 3.498 mg/day.The reason for use was non-malignant pain and radiculopathy.It was reported that there was an empty pump alarm occurring.The rep had access to the patient and an 8840 clinician programmer.The patient missed a refill.The caller stated that the patient was not able to get the pump filled due to an insurance issue.The patient had been getting filled by pentec, and the patient relocated and found a physician to manage their care and pump moving forward.The hcp would like the alarms silenced.The pump alarms were silenced, the pump was updated to a full reservoir at minimum rate.The event date was listed as (b)(6) 2017.The patient was going to be referred to a surgeon for a pump replacement.There were no symptoms reported.There were no further complications reported/anticipated.

Manufacturer Narrative

Additional information indicated that the patient was referred to a surgeon for explant as the device was near end of life.The event is no longer reportable for serious injury, it is reportable for device malfunction.Included 'adverse event <(>&<)> product problem' updated to 'product problem'.'intervention required' no longer applies.'serious injury' updated to 'malfunction'.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep on 2018-apr-30.It was reported that the pump alarms were ordered off per the physician.The patient is being referred for pump replacement, as the pump is near end of life.The managing physician information was provided.There were no further complications reported/anticipated.

• 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: 7472062
• MDR Text Key: 106855571
• Report Number: 3004209178-2018-09560
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Date Device Manufactured: 07/31/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 52 YR