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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

Patient Problem Underdose (2542)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving dilaudid (10.0 mg/ml, 0.480 mg/day) via intrathecal drug delivery pump for non-malignant pain.It was reported that the patient's pump was not working properly.In (b)(6) 2018 the patient went to the emergency room because she was not getting enough medication; the doctor increased the drug by 5%.On (b)(6) 2018 a manufacturer representative (rep) met with the patient and did a dye test, and everything was ok.The drug flow was not checked.When she got a refill on (b)(6) 2018 the doctor said there was more drug in the pump than usual.When the patient called the doctor's office to see what the next step was, she was told the doctor was busy with procedures.She wanted to talk to a rep.No further complications were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional.It was reported that the pump not working properly referred to more medicine than expected in the pump.The actual residual volume was 38 ml and the expected was 34 ml.They were unable to determine the cause of the volume discrepancy and were concerned the patient was not getting the correct dose.They put the correct volume in and entered it into the "interrogator" (thought to refer to the clinician programmer) to resolve the volume discrepancy.The volume discrepancy was not resolved to date.The patient's weight was (b)(6).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: 7534986
• MDR Text Key: 108986670
• Report Number: 3004209178-2018-11566
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• Date Device Manufactured: 09/27/2012
• 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 Age: 56 YR