MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA

Model Number	8780
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Response, Decreased (2271)
Date of Event	07/01/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.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 product surveillance registry (psr) regarding a patient receiving intrathecal morphine (concentration 5mg/ml; dose 0.2403mg/day; lot unknown) via an implantable infusion pump.Indication for use was non-malignant pain.The patient experienced decreased pain relief due to ¿sluggish catheter¿ and catheter occlusion.The patient indicated that he had been getting significant pain relief until recently and now the pump was not working as well as it had been.The most recent pump refill prior to the event was on (b)(6) 2014.The decreased pain relief was diagnosed on (b)(6) 2014 at which time the dose was increased 20% to 0.2886mg/day.Per the hcp, a catheter flush on (b)(6) 2014 cleared a partial occlusion.On (b)(6) 2014 a catheter access port (cap) contrast study was performed which revealed the catheter was sluggish but patent.Per the hcp, this was equivalent to the patient occlusion.The catheter was flushed during pump check on (b)(6) 2014.The pump dose was increased on (b)(6) 2014, and (b)(6) 2015.Dose information for these increases was not provided.The event was considered possibly related to the device or therapy, specifically the entire catheter, and not related to the implant procedure.Event outcome was resolved without sequelae as of (b)(6) 2014.A supplemental report will be submitted if additional information is received.

• Brand Name: ASCENDA
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8722233
• Report Number: 3007566237-2016-00801
• Device Sequence Number: 1807925
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2016
• 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: 01/20/2016
• Initial Report FDA Received Date: 06/21/2019
• 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