MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ANTHEM RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3210

Device Problems Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)

Patient Problem Atrial Flutter (1730)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that the patient presented for a cardioversion for atrial flutter.Upon post-cardioversion interrogation, the device exhibited premature elective replacement indicator and end of life indicator.On (b)(6) 2014 device software was successfully downloaded.

Manufacturer Narrative

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

• Brand Name: ANTHEM RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 3797601
• MDR Text Key: 4529738
• Report Number: 2017865-2014-13213
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: PM3210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z0430
• Patient Sequence Number: 1
• Patient Age: 72 YR