MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA

Model Number 8780

Device Problems Retraction Problem (1536); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

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 device manufacturer representative regarding an issue with a 8780 catheter.It was reported that the hcp placed the catheter and when he went to remove the stylet it would not slide out easily so he attempted to pull harder and the entire catheter and stylet kinked.The hcp then requested a new catheter.There were no environmental/external/patient factors that may have led or contributed to the issue.No patient was involved in this event.The issue was reported as resolved.It was reported that the device would be returned for analysis.No further complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The catheter was returned and analysis identified an anomaly of the catheter that was consistent with implant damage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASCENDA
• 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: 7695356
• MDR Text Key: 114683286
• Report Number: 3007566237-2018-02115
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169783027
• UDI-Public: 00643169783027
• 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,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2018
• 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