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

Model Number	PM3160
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2024-01749.It was reported that the patient presented for a generator change procedure due to normal battery depletion.During the procedure, it was noted that the chronic left ventricular (lv) lead exhibited an elevated capture threshold.The physician intended to replace the lv lead.During the replacement, it was found that the guidewire was failing to be removed from the new lv lead.An additional attempt to remove the guidewire damaged the new lv lead.Thus, no new lv lead was implanted.Programming changes were made on the chronic lv lead to address high capture threshold.When the physician attempted to connect the chronic lv lead to the new pacemaker, it was found that the pacemaker setscrew exhibited loose connections.The pacemaker was not used.The physician continued with second new pacemaker and completed the procedure.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of could not tighten or engage the setscrew was not confirmed.Analysis revealed the user of the torque wrench was not making contact with the setscrew.The setscrew has a new untouched appearance.The user was not making contact with the setscrew.The device was found normal.

• Brand Name: ALLURE QUADRA MP
• Common Device Name: 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: 18568151
• Report Number: 2017865-2024-01748
• Device Sequence Number: 7159890
• Product Code: NIK
• UDI-Device Identifier: 05414734509084
• UDI-Public: 05414734509084
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: PM3160
• Device Lot Number: P000152304
• 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: 01/13/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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