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

Model Number PM2272

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Cardiac Perforation (2513)

Event Date 12/01/2021

Event Type  Death  

Event Description

It was reported that a patient presented in-clinic.Prior examination of the patient have revealed and infection.The patient's pacemaker was explanted on (b)(6) 2021.The patient was recovering and no additional patient consequences were reported.

Manufacturer Narrative

Further information was requested but not received.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.

Manufacturer Narrative

Further information was requested but not received.Correction: h1: report type should be death report, which was not included in prior report.Correction b5:related manufacturer reference numbers added, which was not included in the prior report.Correction b2: should be marked as both "death" and "required intervention to prevent permanent impairment/damage", and death date included.

Event Description

Related manufacturer reference number: 2017865-2022-01183.Related manufacturer reference number: 2017865-2022-01185.New information received notes that the suspected cause of the infection was twidder's syndrome.Additionally, during the procedure, the patient was found to have hypotension, and a resuscitative thoracotomy was performed.Two days following the procedure, the patient suffered a heart attack and passed away.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death was unknown.

Manufacturer Narrative

The reported event was an unknown patient death and infection.The report event was not confirmed.Interrogation results were normal and preliminary test results were acceptable.Visual screen was acceptable and device image was downloaded successfully.A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The product was returned and visual inspection was normal.The cause of infection could not be traced to the device. .

Event Description

New information received notes that the healthcare provider alleged that the patient death was caused by the trauma the patient sustained during the explant procedure to treat the infection.Additionally, a cardiac perforation was alleged, but not confirmed.No dislodgement or migration was noted in the patient.The symptom of hypotension was attributed to the leads, as well as the pacemaker.

Event Description

New information received notes that the suspected cause of the infection was twidder's syndrome.Additionally, during the procedure, the patient was found to have hypotension, and a resuscitative thoracotomy was performed.Two days following the procedure, the patient suffered a heart attack and passed away.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death was unknown.

Manufacturer Narrative

Additional information e1: name of healthcare facility.

• 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: 13041385
• MDR Text Key: 282481193
• Report Number: 2017865-2021-39605
• 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,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000112644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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 ST.; TENDRILLEADS.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 72 YR
• Patient Sex: Female