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

Model Number 863740

Device Problem Difficult to Advance (2920)

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

Event Date 11/05/2006

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2016.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 08-jun-2008, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient receiving an unknown drug via an implantable infusion pump.It was reported that it was "incredibly difficult" to put the catheter in with her previous pump implanted on (b)(6) 2006.The caller further clarified that it took "numerous times" to try to get the catheter placed correctly.Due to the issue the catheter had to be re-placed again on (b)(6) 2006.No further complications have been reported as a result of this event.

• 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: 9853475
• MDR Text Key: 184079547
• Report Number: 3007566237-2020-00320
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2008
• Device Model Number: 863740
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Date Device Manufactured: 09/19/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR