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

Model Number PM3212

Device Problems Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Device Operates Differently Than Expected (2913)

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

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It was reported that the pulse generator had prematurely issued an alert for battery depletion.The device remained in use.No patient symptoms were reported.

Event Description

New information noted that during a follow-up visit on (b)(6) 2014, the pulse generator exhibited a premature end of service indicator.A firmware download restored the device.It was also noted that the patient had received ablation therapy.

Manufacturer Narrative

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

• Brand Name: ANTHEM RF PULSE
• 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: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4235999
• MDR Text Key: 4974065
• Report Number: 2017865-2014-18606
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: PM3212
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2012
• 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