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

Model Number PM2272

Device Problems Failure to Interrogate (1332); No Device Output (1435); Telemetry Discrepancy (1629)

Patient Problem Cardiac Arrest (1762)

Event Date 03/28/2018

Event Type  Injury  

Event Description

It was reported that the patient presented in the operating room for an lvad placement.When the patient was undergoing cauterization, the pulse generator began inhibiting pacing.A magnet was placed on the device for appropriate asynchronous pacing for about five minutes, at this point the device exhibited complete loss of output and the patient became asystolic.A temporary pacemaker was then used to provide pacing support during the procedure.Upon attempted interrogation post procedure, the device was unable to establish strong telemetry connection to run any tests.The patient was in stable condition.On (b)(6) 2018, the device could not be interrogated.The device was explanted and replaced.The patient was in stable condition prior, during and post procedure.

Manufacturer Narrative

The reported field event of no lv output and communication issues was not confirmed in the laboratory.The device was tested on the bench including device output monitoring and telemetry test and no anomalies were found, and battery voltage was still in normal range of operation.Analysis of the connector did not find any issues.User manual states that exposure to electrocautery during the placement procedure could temporarily inhibit the output.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7426017
• MDR Text Key: 105309594
• Report Number: 2017865-2018-05627
• Device Sequence Number: 1
• Product Code: DXY
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: PM2272
• Device Lot Number: A000044701
• Other Device ID Number: 05414734509589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2017
• 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: 57 YR