MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Achieve catheter was inside patient's body and it started to have noise on all channels.New achieve catheter inserted and problem resolved.No injury to patient.

• Brand Name: ACHIEVE
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12908038
• MDR Text Key: 281507998
• Report Number: 12908038
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2021,11/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Lot Number: 222265920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White