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

Model Number PM2272

Device Problems Pacing Problem (1439); Connection Problem (2900)

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

Event Date 01/25/2019

Event Type  malfunction  

Event Description

It was reported that during the procedure, when the ventricular lead was connected to the device, ventricular pacing (vp) was not recorded.The status was not improved after attempting to put the ventricular lead into the device.Therefore, a check on psa was performed to see if this was caused by the lead or the device.When the v lead was connected to the pacemaker system analyzer (psa), the status was improved, and vp was recorded properly.After attempting to connect the v lead to the device again, the issue was not solved.The device was replaced with another device and no reported issue was observed when the v lead was connected to the 2nd device and vp was properly recorded without any problem.The procedure was completed without any adverse consequences to the patient.

Manufacturer Narrative

The reported field event of no lv output and communication issues were not confirmed in the laboratory.Functional analysis of device was performed, including output monitoring and interrogation tests, and no issues or anomalies were found.

• Brand Name: ASSURITY MRI
• 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: 8319180
• MDR Text Key: 135505999
• Report Number: 2938836-2019-00943
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Model Number: PM2272
• Device Lot Number: P000069072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• 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 Age: 90 YR