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

Model Number 8637-40

Device Problem Activation Failure (3270)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who received lioresal baclofen (unknown concentration and dose) in an implantable pump for intractable spasticity an post spinal cord injury.The hcp was able aspirate the pump reservoir and received the correct volume.However the pump could only be fill with 36ml.The drug was aspirated and new drug was added.Following the second attempt, only 36.5ml could filled.The reporter was to follow up with the hcp.There were no reported patient symptoms.Additional information was requested from the hcp regarding drug information, concomitant medications, pertinent medical history, if the cause of the issue was determined, an if the issue resolved.If additional information is received, a follow-up report will be submitted.

• 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: 8722690
• MDR Text Key: 150148687
• Report Number: 3004209178-2016-02901
• 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
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 06/21/2019
• Date Device Manufactured: 11/17/2012
• 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: 48 YR