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

Model Number 8780

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis identified damage occurred to the guidewire during the implant procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative on (b)(6) 2019 regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump.The indication for use was non-malignant pain.It was reported that during the implant procedure the catheter stylet clubs could not be removed from the catheter and the hcp was unable to implant.Another catheter was opened and used.There were no known environmental, external, or patient factors that may have led or contributed to the issue and there were no applicable diagnostics or troubleshooting performed.The issue was considered resolved at the time of report and the patient's status was alive - no injury.No further complications were reported or anticipated.

• Brand Name: ASCENDA
• Type of Device: 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9571074
• MDR Text Key: 174889180
• Report Number: 3004209178-2020-00688
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000051112
• UDI-Public: 00763000051112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR