MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD PROMOTE RF CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number 3207-36

Device Problem Failure to Fire (2610)

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

Event Date 11/19/2010

Event Type  Death  

Event Description

It was reported by the patients spouse that the patient expired.Further information retrieved from the hospital notes that the patient presented to the hospital with complaint of painless hematuria and was admitted.The hematuria was suspected to be due to medication for chronic atrial fibrillation.On the evening of (b)(6) 2010 shortly after midnight, the patient got up on his own, was completely asymptomatic and conversant per the assisting nurse, then became unresponsive and pulseless.Resuscitation efforts failed to sustain him after a brief recovery.It was suspected that since there were no respiratory symptoms and no pain, that it was related to an arrhythmia.It was noted that there was no evidence of the device delivering therapy.While in hospital, the patient had an echo which revealed an ejection fraction of 60 percent.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: PROMOTE RF CRT-D
• 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: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4266726
• MDR Text Key: 17634645
• Report Number: 2938836-2014-18017
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Model Number: 3207-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2009
• 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
• Patient Outcome(s): Death
• Patient Age: 71 YR