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 02/14/2024

Event Type  malfunction  

Event Description

During follow-up, noise leading to oversensing was observed on the right ventricular (rv) lead and right atrial (ra) lead.The oversensing on the ra lead led to inappropriate automatic mode switch.Lead damage was suspected but was not confirmed visually.Noise could be reproduced through provocative testing.It was suspected that the oversensing was due to myopotentials.The device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.There were no adverse consequences.Related manufacturer reference number: 2017865-2024-33795.

• 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: 18810739
• MDR Text Key: 336615150
• Report Number: 2017865-2024-33792
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: PO
• 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: 02/29/2024

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: 08/31/2021
• Device Model Number: 1944/52
• Device Lot Number: P000069068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2018
• 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