MAUDE Adverse Event Report: ABBOTT QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	1258T/92
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a remote follow, high pacing impedance was noted on the left ventricular (lv) lead suspected to be due to non-confirmed lead damage.No intervention has been performed at this time.The patient was in stable condition.
Event or Problem Description
Additional information was received indicating x-ray imaging was performed and damage of the left ventricular (lv) lead was observed.The lv lead was capped and replaced to resolve the event.The patient was in stable condition.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13731958
• Report Number: 2017865-2022-05223
• Device Sequence Number: 4710013
• Product Code: OJX
• UDI-Device Identifier: 05414734502627
• UDI-Public: 05414734502627
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 1258T/92
• Device Catalogue Number: 1258T-92
• Device Lot Number: 3830795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown