MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN SELECT II; CATHETER, PERCUTANEOUS

Model Number 6248V-90P

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

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Low Oxygen Saturation (2477)

Event Date 10/13/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure the right ventricular (rv) and right atrial (ra) leads had been placed and the physician was attempting to gain access to the coronary sinus for the left ventricular (lv) lead implant when the patient went into flash pulmonary edema.The patient's blood pressure dropped along with the oxygen saturation.The patient coded and cardiopulmonary resuscitation was administered for about one hour, however, the patient died.

• Brand Name: ATTAIN SELECT II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10766591
• MDR Text Key: 214073597
• Report Number: 9612164-2020-04177
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00643169184190
• UDI-Public: 00643169184190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123153
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: 6248V-90P
• Device Catalogue Number: 6248V-90P
• Device Lot Number: 0010288395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Date Device Manufactured: 06/24/2020
• 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): Death
• Patient Age: 65 YR
• Patient Weight: 71