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

Model Number	PM3542
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2023-20845.Related manufacturer reference number: 2017865-2023-20847.It was reported that a patient presented with syncope, which was alleged to be due to dislodgement of the left ventricular (lv) and right ventricular (rv) leads.No electrical malfunction was reported.During the procedure to address the lead dislodgement, the patient's pacemaker set screw was unable to accept the hex-wrench, was difficult to loosen from the rv lead, and was damaged.The right atrial lead was also unable to removed from the device header.No malfunction was alleged on the right atrial lead.The lv and rv leads were successfully repositioned on (b)(6)2023.The device was replaced during the procedure on (b)(6)2023.The patient was stable throughout.
Additional Manufacturer Narrative
Further information was requested, but not received.
Additional Manufacturer Narrative
The reported event of difficult to remove the a and v-leads from the a- and v-connector ports was not confirmed.Analysis did not reveal any connector port anomalies that would make the leads hard to remove.Lead insertion and removal force tests showed the test leads inserted and removed with normal force.The setscrews were found untightened and normal when returned from the field and were not holding the leads in the connectors.The device was found to be normal with no anomalies found.Device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 16998242
• Report Number: 2017865-2023-20844
• Device Sequence Number: 11398838
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: P000158788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown