MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

Device Problem Pacing Intermittently (1443)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During an implant procedure for a final-stage cardiac failure pacemaker dependent patient, the left ventricular lead was connected to the device and it was noted that left ventricular pacing was unstable and the device would only intermittently pace.The device remained implanted but the guidewire became stuck in the lead and the lead was exchanged.The patient expired the week following the procedure due to issues related to cardiac failure that were unrelated to the intermittent pacing and there were no performance issues noted with any abbott device.

Manufacturer Narrative

The pacemaker was received for analysis.The report of unstable left ventricular pacing was not confirmed.Analysis found that the setscrew inset was filled with septum debris, preventing proper insertion of the torque wrench which may have interfered with proper tightening of the setscrew.After the debris was removed, the lead was able to be tightened securely onto the pacer connector.Electrical and mechanical testing was performed and no anomalies were noted.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6257451
• MDR Text Key: 65363959
• Report Number: 2017865-2017-00407
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: PM3262
• Device Lot Number: P000033372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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