MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA; CATHETER, INFUSION

Model Number 8780

Device Problem Material Integrity Problem (2978)

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

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a catheter used with an implanted infusion pump.Per the hcp, the catheter was not used as it broke during the procedure and it was discarded in the or (operating room).The hcp could not remember the date of the event or many details, but noted that they didn't think there was a defect with the catheter.The hcp thought it was the patient's anatomy as the patient was a child.The manufacturer representative present at the case further noted that the physician damaged both catheters by bending them before implanting them in the patient.The account reportedly felt it was user error so the catheter was not returned.The device was never implanted, so no additional tunneling was required.There was no impact to the patient and the device wasn't used further.It was specified that the implant was successful.No further complications were reported or anticipated.

• Brand Name: ASCENDA
• Type of Device: CATHETER, INFUSION
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7557247
• MDR Text Key: 109666508
• Report Number: 3007566237-2018-01643
• Device Sequence Number: 1
• Product Code: JCY
• UDI-Device Identifier: 00643169783027
• UDI-Public: 00643169783027
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Date Device Manufactured: 03/20/2018
• 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