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

Model Number PM1272

Device Problems Incorrect Measurement (1383); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/04/2021

Event Type  Death  

Event Description

Related manufacturer reference number: 2017865-2021-40498.It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests the death was device related.No additional information was available.

Manufacturer Narrative

The reported event of incorrect measurement was not confirmed.Device image analysis indicated average current trends were normal and voltage was within normal range of operation.Analysis of device image showed that device was set to auto-capture and rate responsive mode was turned on.When device is set to auto settings the pacing may change based on requirements of the patient and may cause change in estimated longevity and battery measurement.Further analysis did not find any anomaly.Longevity assessment was performed, and device had appropriate longevity remaining.Correction: h6: health impact code should be "death" instead of " additional surgery".

• 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: 13122138
• MDR Text Key: 282995589
• Report Number: 2017865-2021-40497
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: 05414734509572
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: PM1272
• Device Catalogue Number: PM1272
• Device Lot Number: A000105135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Female