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

Model Number PM1272

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-01962.Related manufacturer reference number: 2017865-2022-01963.It was reported that the patient presented in clinic for a post implant check.Device interrogation revealed that the right ventricular lead had high capture thresholds and low sensing.A routine post-implant chest x-ray revealed that the pacemaker had dropped from its original position and caused the right ventricular lead to dislodge.On (b)(6) 2022, the lead was explanted and replaced.The pacemaker was re-implanted and a tyrex pouch was used and the pocket was closed.The patient was stable post procedure.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13361691
• MDR Text Key: 284513357
• Report Number: 2017865-2022-01962
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: 05414734509572
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: PM1272
• Device Catalogue Number: PM1272
• Device Lot Number: P000131096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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 STS
• Patient Outcome(s): Required Intervention