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

Model Number PM2272

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Dizziness (2194)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Related manufacture reference number: 2017865-2024-01356.Related manufacture reference number: 2017865-2024-01357.It was reported that the patient presented at the emergency room, symptomatic of dizziness.Chest x-ray noted the atrial lead and right ventricular lead were dislodged and pulled back and the pacemaker appeared to be flipped in the pocket.Failure to capture was noted on both leads.The right ventricular lead and atrial lead were explanted and replaced on (b)(6) 2024 while the pacemaker remain in use.During the procedure, it was noted that the header of the pacemaker was detached.The header of pacemaker was sutured in place during the revision procedure.The patient was in stable condition.

Event Description

It was reported that the patient presented at the emergency room, symptomatic of dizziness.Chest x-ray noted the atrial lead and right ventricular lead were dislodged and pulled back and the pacemaker appeared to be flipped in the pocket.Failure to capture was noted on both leads.The right ventricular lead and atrial lead were explanted and replaced on (b)(6) 2024 while the pacemaker remain in use.The header of pacemaker was sutured in place during the revision procedure.The patient was in stable condition.

Manufacturer Narrative

The reported of migration was not confirmed.As received, a device was returned for analysis.Final analysis did not identify any anomalies.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 18526816
• MDR Text Key: 333042489
• Report Number: 2017865-2024-01358
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• 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,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2272
• Device Lot Number: A000147634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female