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

Model Number PM3242

Device Problem Failure to Disconnect (2541)

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

Event Date 02/16/2021

Event Type  malfunction  

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

The patient was presented in the hospital for a generator change.During the procedure, it was observed the right ventricular (rv) lead could not be removed from the header of the pacemaker.After several efforts, the rv lead was released from the pacemaker.The patient was in stable condition.

Manufacturer Narrative

The reported complaint of rv-lead difficult to remove from header was not confirmed.No v-connector anomalies were found.The dimensions of the v-connector port were in specifications.The v-connector was tested for the force it takes to remove and insert leads.Lead removal and insertion forces were normal in specification.No blood or foreign material was found in the connector port that would cause the lead to become stuck.The setscrew had been untightened and removed indicating the setscrew was not the cause of the problem.No device anomalies were found that could have caused this problem.An over-sized lead is a possible cause.

• Brand Name: ALLURE QUADRA 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
• MDR Report Key: 11398450
• MDR Text Key: 234235246
• Report Number: 2017865-2021-10841
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4919836
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 89