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

Model Number 6250V-EH

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during implant, the patient's coronary sinus was dissected during coronary sinus access.The catheter was removed and the left ventricular (lv) lead placement was abandoned.The physician chose to place the lv lead into the lv port and coil the lead in the pocket.The patient would return at a later date to place that lv lead.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN COMMAND
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11797557
• MDR Text Key: 249718597
• Report Number: 9612164-2021-01837
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00763000160289
• UDI-Public: 00763000160289
• 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: 05/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: 6250V-EH
• Device Catalogue Number: 6250V-EH
• Device Lot Number: 0010555117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/10/2021
• Date Device Manufactured: 02/05/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 88 YR