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

Model Number PM3562

Device Problems Failure to Interrogate (1332); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

Implant date is estimated to have occurred in 2019.Further information was requested but not received.

Event Description

The patient was admitted to the emergency room on (b)(6) 2021 after an attempted suicide and gunshot wound to the implanted pacemaker.The pacemaker went into back-up vvi (bvvi) mode and the patient felt phrenic nerve stimulation.Then, on (b)(6) 2021, the device was explanted after it was unable to be interrogated.It is unknown if the pacemaker could not be interrogated due to gunshot wound or not.Further information was requested but not received.

Manufacturer Narrative

The reported events of no pacing and failure to interrogate were confirmed.The device was received from the field with no output, no telemetry, and battery having reached end of service.Field information indicates the pacer tripped to backup mode due to a gunshot triggered by the patient causing a large dent on the device.The device image could not be saved due to lack of telemetry and data was requested to the field, but it could not be obtained.Analysis performed after cutting open the device case and replacing the power source indicated high current drained by the hybrid circuitry.Further analysis isolated the high current to a component on the hybrid circuitry, which depleted the battery prematurely, consistent with the reported field events.

• Brand Name: QUADRA ALLURE MP 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12843921
• MDR Text Key: 281013115
• Report Number: 2017865-2021-37182
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000066238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2018
• 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 Outcome(s): Required Intervention