MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8781
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient via healthcare provider who was receiving morphine (5mg/ml at.55 mg/ml) via an implantable pump for unknown indications for use.It was reported that patient presented to the emergency department at st.Vincent with complaints related to cerebra spinal fluid (csf) leak.The healthcare provider removed old catheter and replaced with a new 8781 catheter.Patients dog jumped on her.Environmental factors that have led to the issue was the patient's dog jumped on her.The issue was resolved at time of the report.Patient status alive no injury.
Additional Manufacturer Narrative
Concomitant medical products: product id: 8637-40, lot#: ngv733732h (b)(4), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type :pump; product id: 8637-40, lot#: ngv733732h, implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: pump.Other relevant device(s) are: product id: 8637-40, serial/lot #: (b)(4), ubd: 28-apr-2023, udi#: (b)(4).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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13795713
• Report Number: 3004209178-2022-03403
• Device Sequence Number: 17097026
• Product Code: LKK
• UDI-Device Identifier: 00763000051129
• UDI-Public: 00763000051129
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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: 12/21/2023
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2022
• Initial Report FDA Received Date: 03/17/2022
• Date Device Manufactured: 12/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female