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

Model Number 1948/58

Device Problems Failure to Capture (1081); Fracture (1260); Failure to Sense (1559); Low impedance (2285)

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

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that failure to capture, failure to sense, and low pacing impedance was observed on right ventricular (rv) lead during an unrelated procedure.Loss of capture was reproducible during provocation testing.No intervention was performed and the procedure was completed.The patient is not pacemaker dependent.The rv lead was explanted and replaced at a later date to resolve the event and the patient was in stable condition.A lead fracture was alleged to be the cause of the event, however this was not confirmed via diagnostic imaging or during the explant procedure.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 16974090
• MDR Text Key: 315689695
• Report Number: 2017865-2023-20632
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: 05414734502351
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 1948/58
• Device Catalogue Number: 1948-58
• Device Lot Number: 4160986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2013
• 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
• Patient Outcome(s): Required Intervention