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

Model Number 1258T/75

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that a loss of pacing and episodes of oversensing due to electromagnetic interference was noted.This resulted in the pacemaker dependent patient receiving an inappropriate shock.Furthermore, high out-of-range pacing impedance values were noted on the left ventricular lead.Lead revision is anticipated.Manufacturer reported number: 2938836-2019-05798.

Event Description

Additional information received indicating that during the lead revision, insulation damage was noted on the left ventricular lead.The lv lead was capped and replaced to resolve the event.The patient was stable with no consequences.Manufacturer reported number: 2938836-2019-05798.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8781100
• MDR Text Key: 150719692
• Report Number: 2017865-2019-10760
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502603
• UDI-Public: 05414734502603
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: 1258T/75
• Device Lot Number: 3296341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2010
• 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
• Treatment: UNIFY ASSURA ICD, CD3361-40C
• Patient Outcome(s): Hospitalization; Other; Required Intervention