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

Model Number PM3562

Device Problem Wireless Communication Problem (3283)

Patient Problem Syncope (1610)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The results / method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2938836-2019-15440, related manufacturer reference number: 2938836-2019-15441.It was reported that when the patient presented at the emergency room with symptoms of syncope, complete loss of capture was observed on the left ventricular lead and intermittent loss of capture was observed on the right ventricular lead.It was also noted that the device would not interrogate using wireless communication due to radio frequency telemetry lockout.The leads were re-positioned and the device was explanted and replaced.The patient was stable after the procedure.

Manufacturer Narrative

The reported field event of a wireless communication anomaly was not confirmed in the laboratory.Upon receipt, the device was able to operate with inductive and radio frequency telemetry appropriately.Functional analysis of the device was performed and no anomalies were noted.Longevity assessment was performed and the device was found to be in normal range of operation.

• Brand Name: QUADRA ALLURE MP CRT-P
• 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: 9219258
• MDR Text Key: 163192400
• Report Number: 2938836-2019-15442
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: A000087118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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
• Treatment: QUARTET LEAD; TENDRIL LEAD
• Patient Outcome(s): Required Intervention
• Patient Weight: 80