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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Volume Accuracy Problem (1675)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via company representative regarding a patient receiving medication via an implanted pump.The indication for pump use was post lumbar laminectomy syndrome and non-malignant pain.On (b)(6) 2016 it was reported that they were getting no telemetry with the pump.They had tried 3 different programmers and changed environments.The patient's stimulator was read successfully, so it was unlikely that the issue was emi related.The pump had last been read successfully about one month ago; there was no trouble reading the pump then.At that time there was a volume discrepancy and where they got back more than expected; the reporter did not have the actual numbers.The patient started having withdrawal-type symptoms shortly after the last refill which had come on suddenly and was still not having effective therapy.Additional information was received on (b)(6) 2016 from a company representative and it was reported that after 45 minutes, the pump was re-interrogated and it was able to be read.The pa (physician's assistant) was also able to read the pump and adjusted the daily dose to have an increase of (b)(6) to help with the withdrawal symptoms.The cause of the volume discrepancy, withdrawal-like symptoms, and inability to read the pump was not determined to be linked to anything.As of (b)(6) 2016 the issues were resolved.The pa was going to take the next steps and the reporter was not involved after that.

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: 5818997
• MDR Text Key: 50392169
• Report Number: 3004209178-2016-14848
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2013
• 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: 07/01/2016
• Date Device Manufactured: 07/23/2011
• 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: 35 YR