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

Model Number	8780
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
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
It was reported that patient¿s catheter was kinked.It was reported that the patient was in surgery for a pocket revision because they were getting ready to have a hernia surgery and the general surgeon wanted the pump moved slightly.The catheter was found to not be patent during the surgery.It was reported there was no flow when attempting to aspirate through the side port.It was reported that the doctor was able to unkink the catheter at the anchor sited by removing the anchor.The doctor placed a new anchor and a new colored connector and was able to obtain flow.No environmental/external/patient factors that may have led or contributed to the issue were reported.The patient¿s status was alive with no injuries.The issue was resolved.No symptoms were reported.No further complications were reported or anticipated.

• 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: 10148724
• Report Number: 3007566237-2020-00334
• Device Sequence Number: 13994168
• Product Code: LKK
• UDI-Device Identifier: 00643169783027
• UDI-Public: 00643169783027
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2020
• 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: 06/11/2020
• Initial Report FDA Received Date: 06/12/2020
• 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: 49 YR