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

Model Number PM2272

Device Problems Failure to Capture (1081); Failure to Sense (1559); Connection Problem (2900)

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

Event Date 02/16/2018

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, the pulse generator exhibited loss of right ventricular sensing after the lead was plugged in the ventricular port.A connection issue was suspected.The device was not used and a new device was successfully implanted.The procedure was completed successfully without adverse consequence to the patient.The patient would continue to be monitored.

Event Description

New information noted that the device also exhibited loss of capture on the ventricular channel.

Manufacturer Narrative

The reported field event of loss of sensing, loss of capture and no connection were not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.Analysis performed, including device output monitoring, sensitivity and capture test, did not find anomalies, and battery voltage was still in bol range of operation.Analysis of the device header did not show any anomalies of ra and rv channels.

• Brand Name: ASSURITY MRI
• 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: 7347098
• MDR Text Key: 102723476
• Report Number: 2017865-2018-03880
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• 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,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: PM2272
• Device Lot Number: A000050448
• Other Device ID Number: 05414734509589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 05/24/2018
• Supplement Dates FDA Received: 03/30/2018; 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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: 77 YR