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 04/07/2021

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2021-15640.It was reported that the patient presented in clinic for a device change.During procedure, the right ventricular (rv) lead was unable to be removed from the device header.Multiple attempts were made without success.Silicone oil was applied.The lead was able to be removed after.The rv lead was then connected to a new device.The patient¿s condition was stable.

Manufacturer Narrative

The reported event of difficulty removing the rv lead from the header could not be confirmed.The lead had been removed and the connector port is coated with lubricant which prevents duplicating the problem in the field.Analysis found this device was manufactured 27 mar 2014 and has the original sbp header design which is known to have lead insertion difficulties.With the original sbp header design if the physician managed to insert the leads into the connectors the leads would have to be forced into the connector ports with extreme forces and manipulations.The same or greater extreme forces would then be needed to remove the leads.However, this problem could not be confirmed with this device since test leads removed with normal force and the lead used in the field was not returned.Actions have already been taken to fix the lead insertion anomaly with a re-design of the header.The header re-design has already been implemented to correct the problem.The original sbp header design that this device has is now obsolete.

• 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: 11697176
• MDR Text Key: 246481643
• Report Number: 2017865-2021-15639
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4539167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS
• Patient Age: 83 YR