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

Model Number PM2240

Device Problems Pacing Inadequately (1442); Programming Issue (3014)

Patient Problem Atrial Fibrillation (1729)

Event Date 08/20/2016

Event Type  malfunction  

Event Description

It was reported that the patient presented clinic today for a routine device check.A retrograde conduction test could not be performed as the patient was in atrial fibrillation at the time of the office visit.The caller noted that p waves were falling into pvarp and that atrial pacing pulses delivered afterward appeared to trigger the arrhythmia.The device was reprogrammed successfully.The patient was stable.

• Brand Name: ASSURITY RF 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: 6567416
• MDR Text Key: 75174551
• Report Number: 2017865-2017-03538
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: PM2240
• Device Lot Number: 4893284
• Other Device ID Number: 05414734507073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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 Age: 64 YR