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

Model Number 3213-36

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

It was reported that an alert was not delivered when the device reached eri.The device was at normal eri, and explanted and replaced.The patient was doing well after the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Evaluation description: the reported diagnostic anomaly was confirmed in the laboratory.Based on device settings, a longevity calculation was performed and was found to be within expected limits.The device was tested on the bench, and no anomalies were found.The cause of the reported anomaly was believed to be due to a programmer issue.(b)(4).

• 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: 4310382
• MDR Text Key: 5132587
• Report Number: 2938836-2014-18440
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2008
• Device Model Number: 3213-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/14/2015; 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2008
• 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
• Patient Age: 84 YR