MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/75

Device Problems High impedance (1291); Product Quality Problem (1506); Failure to Sense (1559); Fitting Problem (2183); Capturing Problem (2891); Connection Problem (2900)

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

Event Date 08/10/2021

Event Type  malfunction  

Event Description

It was reported during a biventricular pacemaker implant procedure that the left ventricular (lv) lead would not fully connect to an is-4 connector tool.Upon attaching the lead to testing cables, it exhibited high pacing impedance and inability to sense any signals.The lead was then attached to the pulse generator where it exhibited high capture thresholds.The physician used a different lv lead to complete the procedure.The patient was discharged.The lead was inspected post procedure and it was noted that the insulation distal seemed too large and the connector would not fit over that portion.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Manufacturer Narrative

Correction - medical device problem code should have been product quality problem rather than fitting problem.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12410273
• MDR Text Key: 269441742
• Report Number: 2017865-2021-29281
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1458Q/75
• Device Catalogue Number: 1458Q-75
• Device Lot Number: A000102272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White