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

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Shock from Patient Lead(s) (3162); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Event Description

Medtronic received information that the patient implanted with this annuloplasty ring died.The cause of death and relation to the device was listed as unknown.Further information was received that prior to the patients death, the family reported multiple shocks from the patients implanted aicd.It was determined that a loose aicd wire may have been the cause of the multiple shocks and the faulty aicd wire was removed surgically.The patients heart function was down to 5% and efforts to support heart function were ineffective and the patient expired.The hospital discharge as deceased summary noted that the aicd was firing due to persistent ventricular tachycardia (vt).The patient had severe heart failure (ejection fraction less than 10%).The patient was unable to wean from the ventilator and after a discussion with the family extubated, and treated with comfort care which included turning off of the icd leaving the pacemaker function active, until the patient passed away.No autopsy was requested and the cause of death was documented a multiorgan failure.Pt was 70 inches in height, 86 kg in weight.Additional information was received that the patient was implanted with a st.Jude/ ventritex aicd, right ventricular lead serial number (b)(6), right atrial lead was serial number (b)(6).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE; VENTRITEX
• MDR Report Key: 17525262
• MDR Text Key: 321043135
• Report Number: MW5132203
• 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: 09/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1