MAUDE Adverse Event Report: ABBOTT ISOFLEX OPTIM LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1944/52

Device Problems Failure to Capture (1081); Failure to Sense (1559); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  malfunction  

Event Description

It was reported that during a follow up in clinic, loss of sensing and loss of pacing was noted on the right atrial (ra) lead.The device was reprogrammed to resolve the event.The patient was in stable condition.

Event Description

Additional information was received indicating loss of pacing did not occur.Loss of capture was noted on the right atrial (ra) lead.

• Brand Name: ISOFLEX OPTIM 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16963714
• MDR Text Key: 315767086
• Report Number: 2017865-2023-20524
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: 05414734502320
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 1944/52
• Device Catalogue Number: 1944-52
• Device Lot Number: P000155600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/01/2023; 06/21/2023
• Supplement Dates FDA Received: 06/06/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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