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

Model Number	6248V-90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant of the left ventricular (lv) lead, the catheter broke while being slit.The catheter was removed, and the lv lead was checked and all measurements were within a normal range.The day after the implant procedure, the left ventricular (lv) lead exhibited high, undefined impedances and loss of capture.The pocket was opened and it was noted the lv lead was fractured in two pieces.The lv lead was explanted.A replacement lv lead implant was attempted, but the lead could not be delivered to a stable area.The replacement lv lead was removed and the patient was later implanted with an epicardial lead.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10531493
• Report Number: 9612164-2020-03450
• Device Sequence Number: 11527042
• Product Code: DQY
• UDI-Device Identifier: 00643169143210
• UDI-Public: 00643169143210
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: 6248V-90
• Device Catalogue Number: 6248V-90
• Device Lot Number: 0009306386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR