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

Model Number	8781
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.
Event or Problem Description
Information was received from a foreign healthcare provider (hcp) via a business partner regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use.It was reported that during the implant procedure (unknown date), the collet disconnected from the connector when the physician gripped the connector.There was no reported patient impact.No complications were reported.There were no known environmental/external/patient factors that may have led or contributed to the issue.The catheter was not used and returned to the manufacturer.No patient complications were reported/anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer representative (confirmed via healthcare provider) indicated the event was considered completed with the use of a second catheter because there were no further reported issues.
Additional Manufacturer Narrative
Analysis of the catheter, model# 8781, serial# (b)(4), found a the collet was detached from the catheter to catheter connector.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7554494
• Report Number: 3007566237-2018-01630
• Device Sequence Number: 11062996
• Product Code: LKK
• UDI-Device Identifier: 00643169359154
• UDI-Public: 00643169359154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 11/16/2019
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N769197004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 07/15/2018; 08/08/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/05/2018; 07/18/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1