MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CRMD ATLAS PLUS HF CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number V-341

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)

Patient Problems Loss of consciousness (2418); Shock from Patient Lead(s) (3162)

Event Date 12/11/2011

Event Type  Injury  

Event Description

It was reported that a pt presented in the hospital after losing consciousness.Shock was delivered, device printouts revealed episodes had been detected in the vf zone.Stored electrograms showed unclear traces of possible vf with undersensing or noise with oversensing and pacing inhibition.The device was explanted.

Manufacturer Narrative

All info provided by mfr, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Eval description : the reported sensing anomaly in the field was confirmed after review of the stored electrogram data.The pts worsening cardiac condition progressed to a phase where large-amplitude, multiple-morphology, qrs-like waves coexist with small, vf-like waves, in between.The back and forth of this pts rhythm causes some apparent under-sensing.

• Brand Name: ATLAS PLUS HF CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CRMD; 15900 valley view ct; slymar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC., CRMD; 15900 valley view ct; slymar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct; slymar, CA 91342 ; 8184932621
• MDR Report Key: 3868395
• MDR Text Key: 4457122
• Report Number: 2938836-2014-01939
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2007
• Device Model Number: V-341
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2011
• Device Age: 63 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/12/2011
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1580, RE17496
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR