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

Model Number 1948/58

Device Problem Signal Artifact/Noise (1036)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that during a remote follow up, noise was noted on the right ventricular (rv) lead.Abbott technical support was contacted, however, no intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

Event Description

Additional information was received indicating the device was reprogrammed.The patient was in stable condition.

• 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: 18996065
• MDR Text Key: 338885074
• Report Number: 2017865-2024-37066
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: 05414734502351
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1948/58
• Device Lot Number: P000165752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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