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

Model Number	8780
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2013, product type: pump.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2020, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving dilaudid (20 mg/ml, 4.5 mg/day) via an implantable pump for non-malignant pain and chronic low back pain.The patient had their pump replaced on the date of this report for a routine pump replacement due to the pump reaching estimated replacement indicator (eri).After disconnecting the suture-less connector of the 8780, the hcp saw some tissue in the cap and chose to replace the pump segment.There were no known external factors and no diagnostics were performed.The pump segment was replaced with a 8784 revision kit.The spinal segment of the 8780 remained in place and still in use.The issue was resolved at the time of this report.

• 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: 9707346
• Report Number: 3007566237-2020-00239
• Device Sequence Number: 19701736
• Product Code: LKK
• UDI-Device Identifier: 00613994555595
• UDI-Public: 00613994555595
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 04/01/2015
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR