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

Model Number	8782
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Pain (1994); Swelling (2091); Headache, Lumbar Puncture (2186); Fluid Discharge (2686)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
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 professional (hcp) via a clinical study.No pump was implanted at time of event and therefore no medication was being delivered.It was reported on (b)(6) 2017 the patient called reporting pain and swelling over the spinal incision site.No fever was reported.The patient was told to go to the emergency room (er) or urgent care since no doctor was available at primary clinic.On (b)(6) 2017 the hcp received a call from the er stating the patient was present with the same symptoms as above plus a positional/spinal headache.The patient was on antibiotics, but no fever and infection unlikely.It was noted there was clear fluid draining from incision.On (b)(6) 2017 examination confirmed the same symptoms and an epidural blood patch was performed.The outcome of the event resolved without sequelae on (b)(6) 2017.The clinical diagnosis was spinal headache.The patient's weight was 120 pounds.The etiology of the event indicated the relationship of the event to the device or therapy was not related and indicated the relationship of the event to the implant procedure was related (surgery/anesthesia).The event date was (b)(6) 2017.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 8695870
• Report Number: 3007566237-2019-01292
• Device Sequence Number: 1889481
• Product Code: LKK
• UDI-Device Identifier: 00643169202146
• UDI-Public: 00643169202146
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 05/05/2018
• Device Model Number: 8782
• Device Catalogue Number: 8782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 11/02/2020
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 54