MAUDE Adverse Event Report: ABBOTT ISOFLEX OPTIM LEAD; Permanent defibrillator electrodes

Model Number 1944/52

Device Problems Break (1069); Over-Sensing (1438); Pacing Problem (1439)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

During an in clinic follow up, noise resulting in oversensing and inappropriate mode switching was observed on the atrial lead.Lead insulation damage was suspected.No intervention has been performed at this time.The patient was stable and will continue being monitored.

Manufacturer Narrative

Further information was requested but not received.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: Permanent defibrillator electrodes
• 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: 17788687
• MDR Text Key: 323926356
• Report Number: 2017865-2023-46656
• Device Sequence Number: 1
• Product Code: NVY
• 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
• Report Date: 09/21/2023

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 Expiration Date: 11/30/2020
• Device Model Number: 1944/52
• Device Lot Number: P000054388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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