MAUDE Adverse Event Report: ST. JUDE MEDICAL RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122

Device Problems High impedance (1291); Protective Measures Problem (3015)

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

Event Date 05/07/2023

Event Type  malfunction  

Event Description

Alert: rv defib lead impedance warning on (b)(6) 2023.From week 26 (b)(6), rv pacing and shock impedances increased.There were no episodes of oversensing stored.Sic was 0.As already mentioned by the cardiac physiologist, at the same time, r wave amplitude increased, and the patient activity decreased.Day/night avg v.Rates are also merging ~70 bpm.The changes in r-wave amplitudes could be related to the clinical condition of the patient or to changes at the tip-tissue interface.Also, the fluctuations on rv bipolar and shock impedances appear to be more related to the patient?s clinical condition.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17488272
• MDR Text Key: 320686848
• Report Number: MW5120971
• Device Sequence Number: 1
• Product Code: NVY
• 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: 06/02/2023

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?: No
• Device Model Number: 7122
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1