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

Model Number 3213-36

Device Problems Failure to Capture (1081); Under-Sensing (1661)

Patient Problem Loss of consciousness (2418)

Event Date 05/06/2011

Event Type  Injury  

Event Description

It was reported that patient collapsed and brought to the hospital.It was noted the icd has not given a treatment.Undersensing on the rv lead and no capture during threshold testing was noted.Later reported the patient expired.There is no allegation from a healthcare professional that the patient's death is device related.

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 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.

• Brand Name: PROMOTE RF CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DIFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3868190
• MDR Text Key: 4455531
• Report Number: 2938836-2014-03957
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/31/2009
• Device Model Number: 3213-36
• Device Catalogue Number: SMTFY99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/06/2011
• Device Age: 36 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/06/2011
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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: 7120/65 AHA18396
• Patient Outcome(s): Hospitalization; Required Intervention