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

Model Number PM2272

Device Problem Pacing Problem (1439)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that during generator change after connecting a device to a pacing lead, the device started pacing at 100 beats/min at ddd mode.An atypical behavior was recorded on the screen and even after changing modes, it will go back to that state.Therefore, device was not used and was replaced with a different generator.In addition, in this procedure the atrial lead show to have the insulation being breached in the pocket and there was noise oversensing on the channel of the lead.The physician asked to add suture sleeve for this lead.All tests were normal.Lead remains implanted.Related manufacturer reference number:2017865-2022-48973.

Manufacturer Narrative

The reported event of pacing problem were not confirmed.Device was in normal range of operation on receipt.Device image analysis indicated average monthly voltage and current trends were normal.Visual analysis was performed and no anomaly was noted.Telemetry, output, pacing magnet detection function were analyzed and no anomalies were noted.Longevity assessment was performed, and device had appropriate longevity remaining.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16006412
• MDR Text Key: 307094242
• Report Number: 2017865-2022-48972
• Device Sequence Number: 1
• Product Code: LWP
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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: 05/31/2024
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000133680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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
• Treatment: TENDRIL
• Patient Sex: Female