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

Model Number 5820

Device Problems No Device Output (1435); Capturing Problem (2891)

Patient Problems Syncope (1610); Bradycardia (1751)

Event Date 11/05/2013

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital not feeling well.The patients heart rate was 35 beats per minute.The pulse generator exhibited an output anomaly and intermittent loss of capture.After re-programming the parameters, normal function resumed.The patient was in good condition after.On (b)(6) 2013, the device was explanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Final analysis found normal device 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: 3559778
• MDR Text Key: 4052349
• Report Number: 2017865-2014-00945
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: 5820
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/05/2013
• Device Age: 11 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2012
• 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
• Patient Outcome(s): Hospitalization