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

Model Number 7122Q

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

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

Event Type  malfunction  

Event Description

(b)(6), caller asking about the gradual increase in this patient's rv bipolar impedance resulting in a rv pacing impedance out of range alert? explained to the caller that there appears to be possible mineralization/calcification on the rvring electrode.Recommended that they contact st.Jude for confirmation of a cause for the gradual increase in the 7122q rvbipolar impedance.(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: 17488284
• MDR Text Key: 320751736
• Report Number: MW5120982
• 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: 7122Q
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1