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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 8840, serial# unknown, product type programmer, physician.

Event Description

Information was received from a consumer via a company representative regarding a patient who was receiving fentanyl of unknown concentration at an unknown dose rate via an implantable pump for non-malignant pain.It was reported that they were unable to interrogate the pump.The event occurred during servicing on (b)(6) 2016.The patient was being seen in the office to have her daily rate decreased but the company representative was unable to interrogate her pump.It was suspected that the pump was flipped.Diagnostics/troubleshooting performed included an ultrasound and palpation.No actions or interventions were taken to resolve the issue; no surgical intervention occurred nor was planned.The issue was unresolved at the time of the report.The patient was without injury regarding their status as of (b)(6) 2016.It was noted that there were no environmental/external/patient factors that may have led or contributed to the issue.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.No patient symptoms were reported.On (b)(6) 2016, a company representative reported that the patient had a follow-up appointment scheduled for (b)(6) 2016 and no further information would be available until then.On (b)(6) 2016, a company representative reported that they had seen the patient in the office on (b)(6) 2016 and they were able to interrogate the pump and reduce her rate.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5938216
• MDR Text Key: 54280016
• Report Number: 3004209178-2016-18568
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2016
• Date Device Manufactured: 06/03/2013
• 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: 88 YR