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

Model Number 5620

Device Problem No Device Output (1435)

Patient Problem Bradycardia (1751)

Event Date 07/28/2014

Event Type  Injury  

Event Description

It was reported that immediately following the conclusion of a routine pulse generator replacement procedure, no output was observed from the new device.The patients intrinsic rhythm was 30 beats per minute.The pocket was reopened and a new lead was implanted but pacing did not begin.The device was explanted and replaced.The new device showed normal functionality and the patient would be monitored.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Final analysis found normal device characteristics.

• Brand Name: ZEPHYR XL SR
• 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: 4073912
• MDR Text Key: 4893251
• Report Number: 2017865-2014-16877
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: 5620
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• 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: 87 YR