MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA

Model Number	8784
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: product id: 8785, lot# : hg55zge, product type: catheter.Other relevant device(s) are: product id: 8785, serial/lot #: (b)(4), ubd: 16-mar-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a healthcare provider (hcp) via company representative (rep) regarding a patient who was receiving dilaudid (unknown concentration or dose) via implantable infusion pump.It was reported that the collet was broken during the procedure prior to implant.There were no known factors that may have led or contributed to the issue.Troubleshooting was not performed.A new kit with a new coupler was opened.The issue was resolved at the time of report.

• Brand Name: ASCENDA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12362693
• Report Number: 3004209178-2021-12868
• Device Sequence Number: 19879080
• Product Code: LKK
• UDI-Device Identifier: 00763000051143
• UDI-Public: 00763000051143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 8784
• Device Catalogue Number: 8784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1