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

Model Number PM3562

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Intermittently (1443)

Patient Problem Syncope (1610)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer report number: 2017865-2020-12580.It was reported that the patient experienced syncope and was dependent on the device for normal function.It was noted during a follow up in clinic that noise, oversensing reproducible with pocket manipulation and arm movements and pause episodes (pacing stopped) were observed on the right ventricular lead and device.A device header anomaly and myopotentials were also suspected and electromagnetic interference (emi) was ruled out.Programming changes were made.The right ventricular lead and device were explanted and replaced.The patient was stable before, during and after the procedure.

Manufacturer Narrative

Final analysis noted the complaint of oversensing, pacing anomaly, and defective device were not confirmed.The device was received from the field in normal working conditions with battery voltage near beginning of life level.Atrial and ventricular sensitivity test under nominal conditions indicated results were normal and within expected sensitivity range.Further evaluation of the output parameter under nominal conditions found all parameters within normal range of operation.Electrical and mechanical tests performed were normal.Additionally, visual inspection of the header and connectors detected no contaminants or foreign material that could contribute to the reported complaints.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: QUADRA ALLURE MP 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
• MDR Report Key: 10473519
• MDR Text Key: 205010962
• Report Number: 2017865-2020-12581
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000082036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS
• Patient Outcome(s): Required Intervention