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

Model Number	1258T/92
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange, an increase in capture threshold and diaphragmatic stimulation were noted on the left ventricular (lv) lead once the new device was implanted.The lv lead was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported events of extra cardiac stimulation and inadequate capture were not confirmed.As received, a partial lead was returned in two pieces.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual examination did not find anomalies with the exception of procedural damage.

• 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: 13392638
• Report Number: 2017865-2022-02168
• Device Sequence Number: 17238847
• Product Code: OJX
• UDI-Device Identifier: 05414734502627
• UDI-Public: 05414734502627
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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): 03/18/2022

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: 05/31/2019
• Device Model Number: 1258T/92
• Device Catalogue Number: 1258T-92
• Device Lot Number: A000023741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEVICE
• Patient Sex: Unknown