MAUDE Adverse Event Report: ST. JUDE MEDICAL LV LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1458Q

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877)

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

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was exhibiting noise and oversensing on the left ventricular (lv) lead channel.Technical services (ts) examined presenting electrograms (egm) and provided troubleshooting including reprogramming options.There was lv pacing inhibition on the presenting egm, however, none was greater than two seconds.Patient was tested further in clinic and noise could not be reproduced, lv impedance and other measurements were noted to be stable and within normal range, this lv lead is a non-boston scientific product.No adverse patient effects were reported.Currently, the crt-d system remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LV LEAD
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17489259
• MDR Text Key: 320697664
• Report Number: MW5121840
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1458Q
• Patient Sequence Number: 1