MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP

Model Number 8637-20

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/27/2017

Event Type  malfunction  

Event Description

Baclofen pump implanted on (b)(6) 2017.Pump did not function appropriately.Pump and catheter removed and replaced on (b)(6) 2017.Pending return to manufacturer.

• Brand Name: MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP
• Type of Device: SYNCHROMED II PROGRAMMABLE PUMP
• Manufacturer (Section D): MEDTRONIC ; minneapolis MN 55432
• MDR Report Key: 6566580
• MDR Text Key: 75308036
• Report Number: MW5069765
• Device Sequence Number: 1
• Product Code: LKK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 49