MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

Device Problem Output Problem (3005)

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

Event Date 03/21/2019

Event Type  malfunction  

Event Description

It was reported that during the implant procedure after connecting the leads to the pulse generator, all leads were tested and were within normal limit.The patient was then externally cardioverted to return to normal sinus rhythm from atrial fibrillation.The leads were again tested, and it was noted that during atrial pacing it was capturing both the right atrium and left ventricle.The left ventricular impedance was lower through device compared to when tested with the pacemaker system analyzer.It was confirmed the leads were in the correct ports and had not dislodged.The leads were disconnected from the device and tested; all leads had appropriate capture and sensing.The device was not used, and a new device was successfully implanted.The patient was in stable condition throughout the procedure.

Manufacturer Narrative

The reported event of output anomalies was confirmed.Device was received with battery voltage at bol level.Device functionality was tested in various settings and found a pacing output anomaly where output pulses were delivering in both ra and lv channels when only one of them was configured to pace, as reported in the field.Testing of the internal components and circuitry, indicated that the reported output anomalies are consistent with integrated circuit anomaly.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8481297
• MDR Text Key: 140874292
• Report Number: 2017865-2019-04971
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: PM3262
• Device Lot Number: A000072539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• 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: 69 YR