MAUDE Adverse Event Report: ST. JUDE DEFIBRILLATOR DR/VR/HF

Model Number V243

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Fall (1848); Loss of consciousness (2418)

Event Date 02/02/2013

Event Type  Death  

Event Description

Device was implanted on (b)(6) 2013, caller's husband passed away 3 years later.On the afternoon of his death, caller stated she noticed he was bent over.He explained to her he was preparing himself for a shock but the defibrillator failed to shock.Caller's husband then tried to walk into the house and fell.The ambulance was called, but due to the snow storm they had to wait outside on the floor for a significant amount of time.The caller stated her husband became unresponsive.Once they arrived at the hospital, the doctors informed the caller her husband had a faint line and he passed away.

• Brand Name: DEFIBRILLATOR DR/VR/HF
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 6540398
• MDR Text Key: 74398934
• Report Number: MW5069491
• Device Sequence Number: 1
• Product Code: NIK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V243
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR