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

Model Number	8780
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)
Date of Event	03/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id 8637-20, serial# (b)(4), implanted: (b)(6) 2015, product type: pump.A good faith effort will be made to obtain the applicable information relevant to the report.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 manufacture's representative regarding a patient receiving morphine at a concentration of 15.0 mg/ml and a dose of 4.817 mg/day via an implanted pump.The indication for use was spinal pain.It was reported the patient had their whole pump system explanted on (b)(6) 2017 and the patient presented to the emergency room (er) with spinal headache and csf leak on (b)(6) 2017.It was indicated the event was related to the implant procedure.It was noted that on (b)(6) 2017 surgical repair of the csf leak was performed.The event resulted in the patient being hospitalized and prolonged hospitalization.The event was ongoing at the time of the event.No further complications anticipated.
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: 6402308
• Report Number: 3007566237-2017-00961
• Device Sequence Number: 13591447
• Product Code: LKK
• UDI-Device Identifier: 00613994555595
• UDI-Public: 00613994555595
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2017
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Device Lot Number: N522555006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR