MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ZEPHYR XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5826

Device Problem No Device Output (1435)

Patient Problem Dyspnea (1816)

Event Date 11/04/2013

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room with shortness of breath.Upon interrogation, the pulse generator exhibited loss of output.The device was explanted and replaced.The patient would be monitored.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Final analysis of the pulse generator found that battery depletion had occurred, resulting in the loss of output seen in the field.The cause of the battery depletion could not be determined.When tested with an external power supply, the pulse generator exhibited normal characteristics.

• Brand Name: ZEPHYR XL DR
• 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: 3555616
• MDR Text Key: 4212728
• Report Number: 2017865-2014-00554
• 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
• 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: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 5826
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/04/2013
• Device Age: 26 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/04/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2011
• 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): Required Intervention
• Patient Age: 51 YR