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

Model Number PM2210

Device Problems Under-Sensing (1661); Device Operates Differently Than Expected (2913); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

It was reported that an asymptomatic patient presented in-clinic for a scheduled follow up.Upon interrogation, it was revealed that the device was experiencing a combination of competitive atrial pacing and intermittent atrial undersensing.There were large number of auto mode switch episodes which appeared to be caused by competitive atrial pacing as well as intermittent atrial undersensing of true atrial fibrillation that was causing the device to go into and out of ams regularly.The atrial sensitivity was reprogrammed.Post ventricular atrial refractory period (pavrp) was not reprogrammed.The patient was stable prior, during and post procedure.The patient will continue to be monitored.

• Brand Name: ACCENT DR RF PACEMAKER
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 6989225
• MDR Text Key: 90847643
• Report Number: 2017865-2017-33842
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: PM2210
• Device Lot Number: 3821653
• Other Device ID Number: 05414734503617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• 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 Age: 88 YR