MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a few days post-operatively to a successful cryo ablation procedure, the patient presented to the clinic with signs and symptoms indicative of pericarditis.The patient experienced chest tightness, cough, sore throat, and hemoptysis.The patient was administered medications for a few days, which resolved the acute pericarditis.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

The patient is a participant in a clinical study.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10005947
• MDR Text Key: 189565285
• Report Number: 9612164-2020-01704
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169467385
• UDI-Public: 00643169467385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• 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,Followup
• Report Date: 08/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2021
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 218413538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/03/2020
• Date Device Manufactured: 09/06/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 93