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

Model Number PM1240

Device Problems Difficult to Interrogate (1331); Pacemaker Found in Back-Up Mode (1440)

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

Event Date 12/18/2018

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 asymptomatic patient presented in clinic.It was revealed that the device entered backup vvi.Firmware downloads were unsuccessful and interrogation was difficult on multiple programmers.No intervention was performed.

Manufacturer Narrative

The reported field event of backup vvi (bvvi) could not be confirmed in the laboratory.The device was received in bvvi mode.The wrong product code was reloaded in the field resulting in the backup condition found when the product was received.The cause of the original bvvi could not be determined due to the original device image being overwritten in the field.The backup condition could not be reproduced in the laboratory.The device was tested on the bench and no anomalies were found.

Event Description

New information revealed that the device was explanted.

Manufacturer Narrative

The previous supplemental report should not have been submitted.The device explant was not performed as a result of a device malfunction.The reported field event of backup vvi (bvvi) could not be confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

• Brand Name: ASSURITY SR RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8209518
• MDR Text Key: 131831739
• Report Number: 2938836-2019-00028
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: PM1240
• Device Lot Number: S000002064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• 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