MAUDE Adverse Event Report: ST. JUDE MEDICAL RV LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 1580

Device Problems Device Sensing Problem (2917); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem Ventricular Fibrillation (2130)

Event Date 11/30/2022

Event Type  Injury  

Event Description

Patients programmed vf and vt rate were higher than actual vf/vt event pt was hospitalized in icu and received cpr alert: rv lead integrity warning on (b)(6) 2022 (2 or more criteria met).Review high rate-ns episodes, sensing integrity counter {short v-v intervals) and rv lead impedance.The oldest high rate-ns episode associated with this observation is dated (b)(6) 2022.(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: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17488975
• MDR Text Key: 320689679
• Report Number: MW5121674
• Device Sequence Number: 1
• Product Code: LWS
• 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: 01/24/2023

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: 1580
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1