MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; NO MATCH

Model Number PM3242

Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: (b)(4) it was reported that the patient presented to the hospital for a scheduled implant procedure.During procedure, the right ventricular (rv) lead was found difficult to be removed from the pacemaker header.The rv lead was removed using another hex wrench compatible to the pacemaker header setscrew while using silicon oil to disconnect the rv lead pin.The pacemaker was successfully explanted and replaced.The rv lead was connected to the new pacemaker and was found to function as intended.Patient was in stable condition.

Manufacturer Narrative

The reported event great difficulty removing the v-lead from the header was confirmed.Analysis revealed this device has the original scalable brady pacemaker (sbp) header design, which is known to have lead insertion and removal difficulties.Actions have been taken to prevent reoccurrence.A header re-design has been implemented to correct this issue.No other anomalies were seen.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18051084
• MDR Text Key: 327162728
• Report Number: 2017865-2023-50441
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 02/29/2016
• Device Model Number: PM3242
• Device Lot Number: 4749467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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: LEFT VENTRICULAR QUARTET LEAD; RIGHT ATRIAL TENDRIL LEAD
• Patient Age: 85 YR
• Patient Sex: Male