MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY¿ CORE SR, JPD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM1152

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that during implant procedure, the set screw in the header of the pacemaker failed to be tightened and the lead could not be connected.The procedure was completed using an alternate pacemaker on (b)(6) 2023.There were no patient consequences.

Manufacturer Narrative

The reported event of not being able to tighten setscrew was confirmed.Final analysis found the user of the wrench was incorrectly partially inserting the torque wrench into the setscrew inset.This caused the wrench to slip while tightening the setscrew then strip that portion of the inset.The setscrew cannot be tightened while it is stripping the inset.No anomalies were detected aside from damages sustained during procedure.

• Brand Name: ENDURITY¿ CORE SR, JPD
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18030366
• MDR Text Key: 326860415
• Report Number: 2017865-2023-50996
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: 10/31/2022
• Device Model Number: PM1152
• Device Lot Number: P000121998
• 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: 10/10/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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