MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5826

Device Problems Device Displays Incorrect Message (2591); Programming Issue (3014)

Patient Problem Muscle Stimulation (1412)

Event Date 01/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experiencing pocket stimulation presented in clinic.A merlin programmer was not present at the clinic to interrogate the device.Once a programmer was available and the device was interrogated, it exhibited an error message regarding programing parameter change error.It was suspected that a device software download was performed incorrectly causing the device to exhibit evvi.The device was reprogrammed successfully and the patient no longer experienced pocket stimulation.

• Brand Name: ZEPHYR XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6381335
• MDR Text Key: 69384389
• Report Number: 2017865-2017-01455
• Device Sequence Number: 1
• Product Code: LWP
• 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: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 5826
• Device Lot Number: 4342562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• 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 Age: 82 YR