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

Model Number V-367

Device Problems Difficult to Interrogate (1331); Pacing Problem (1439)

Patient Problem Heart Failure (2206)

Event Date 01/02/2012

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic due to decompensation.The device was unable to interrogate.The egm showed no biventricular stimulation.The device was explanted.

Manufacturer Narrative

All information provided by manufacturer, 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.This historical complaint is being filed as part of 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.Evaluation: the reported field event of no pacing was confirmed in the laboratory via review of stored electrograms in the laboratory.The reported filed event of communication none was confirmed in the laboratory.The device was tested on the bench and our automated testing equipment.Analysis found internal damage between the anode and cathode separators, causing an internal short of the battery.This damage resulted in premature depletion of the battery.(b)(4).

• Brand Name: ATLAS II PLUS HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4170122
• MDR Text Key: 4874319
• Report Number: 2938836-2014-02906
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Model Number: V-367
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/11/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/02/2012
• Device Age: 40 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/04/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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: 7071/65, (B)(4)
• Patient Outcome(s): Required Intervention