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

Model Number PM1240

Device Problems Pacemaker Found in Back-Up Mode (1440); Operating System Version or Upgrade Problem (2997)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented during a follow up in clinic.The pacemaker went into backup vvi mode upon a failed attempt to perform cyber security update in clinic.Device restoration was not successful.No intervention was performed at the time.Additional information was not reported.

Event Description

New information received on 10/22/2018 indicated that patient presented for procedure.The device was explanted and replaced.The patient was stable post procedure.

Manufacturer Narrative

The reported field event of backup vvi (bvvi) was confirmed in the laboratory.The device was tested on the bench the cause of the bvvi was consistent with hardware anomaly.Correction: this supplemental report is to correct the previously submitted report to include patient ethnicity and race.

• Brand Name: ASSURITY SR RF
• 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: 7958757
• MDR Text Key: 123501656
• Report Number: 2017865-2018-15215
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734507066
• UDI-Public: 05414734507066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• 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,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: PM1240
• Device Lot Number: A000007922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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