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

Model Number PM3562

Device Problems Loose or Intermittent Connection (1371); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/22/2021

Event Type  malfunction  

Event Description

It was reported the patient presented in the hospital for a pacemaker implant procedure.It was observed there was a clicking sound coming off the torque wrench when connecting to the a-lead.The set screw was became stripped.It was also noted that silicone chips may have entered the screw holes.The physician elected to use another pacemaker to complete the procedure.The patient experienced no symptoms related to this procedure.

Event Description

It was reported the patient presented in the hospital for a pacemaker implant procedure.It was observed the set screw became stripped.It was also noted that silicone chips may have entered the screw holes.The physician elected to use another pacemaker to complete the procedure.The patient experienced no symptoms related to this procedure.

Manufacturer Narrative

Correction: h6.

Manufacturer Narrative

Customer complaint of stripped a was confirmed.Visual examination of the header found atrial septum and setscrew damaged and stripped.Left ventricular setscrew was removed and not returned, lv septum had setscrew particles consistent with stripping and removal of setscrew.Stripping of setscrews are consistent with overturning of the torque wrench and inserting the torque wrench at an angle.Performed dhr review to ensure that each manufacturing and inspection operation was performed.The product passed all quality control tests prior to its distribution.The pacer was received in normal working conditions with battery voltage above eri.Electrical analysis performed, indicated normal device functionality.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: QUADRA ALLURE MP 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: 12070961
• MDR Text Key: 258637813
• Report Number: 2017865-2021-24134
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000120430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1