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

Model Number 1944/52

Device Problems Failure to Capture (1081); Failure to Sense (1559); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

During follow-up, loss of capture and sensing were observed on the right atrial (ra) lead.X-ray imaging was performed and revealed the ra lead to be stretched and possibly micro-dislodged.The event was resolved by reprogramming the device.The patient was in stable condition and experienced no adverse consequences.

• 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: 17824596
• MDR Text Key: 324351370
• Report Number: 2017865-2023-47104
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: 05414734502320
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2023

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: 05/31/2023
• Device Model Number: 1944/52
• Device Lot Number: P000105029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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