MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA

Model Number	8780
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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
• MDR Report Key: 7695356
• Report Number: 3007566237-2018-02115
• Device Sequence Number: 789944
• Product Code: LKK
• UDI-Device Identifier: 00643169783027
• UDI-Public: 00643169783027
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2018

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/15/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1