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

Model Number 1948/58

Device Problems Incorrect Measurement (1383); Capturing Problem (2891); Unstable Capture Threshold (3269)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.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

During a follow-up in clinic, variable capture threshold was noted on the right ventricular (rv) lead.The cardiac physiologist suspects a malfunction on the lead, however, no intervention was performed.The patient was stable.

Event Description

Additional information received confirmed capture threshold continues to rise which is incorrectly shown as a loss of capture on the electrogram.

Manufacturer Narrative

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

Additional information received confirmed the device was reprogrammed to resolve the event.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11051027
• MDR Text Key: 223136921
• Report Number: 2017865-2020-23261
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: 05414734502351
• Combination Product (y/n): N
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 1948/58
• Device Catalogue Number: 1948-58
• Device Lot Number: P000044306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1