MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)

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

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot# 0205540503, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: , udi#:.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving lioresal [2000 mcg/ml] at an unknown dose via an implantable pump for multiple sclerosis.It was reported that during a pump replacement due to end of service (eos) when connecting the pump they noticed that the catheter was very stiff where it enters into the connector and the surgeon thought it was fractured.He removed and cut this part of the catheter and connected a new connector.It was indicated the catheter would be returned.The patient had no symptoms.There were no environmental/external/patient factors that may have led or contributed to the issue.No diagnostics or troubleshooting was performed.At the time of the report the issue was resolved and the patient status was "alive - no injury." no further complications were reported or anticipated.

Manufacturer Narrative

Lot number of the catheter was reported as (b)(4) but the ubd and udi are not available as this is not a valid lot number.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received noted that the pump would not be returned as it was disposed of since there was no issue with the pump.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7798840
• MDR Text Key: 117701825
• Report Number: 3007566237-2018-02481
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• 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: 50 YR