MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7122Q/65

Device Problems Over-Sensing (1438); Product Quality Problem (1506); Fitting Problem (2183)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

During an initial implant procedure it was noted that the right ventricular (rv) lead was over-sensing noise leading to pacing inhibition.Additionally, the physician attempted to advance multiple connector sleeves into the rv lead unsuccessfully.The rv lead was not used and a new rv lead was successfully implanted on (b)(6) 2021.The patient was stable throughout the procedure.

Manufacturer Narrative

Correction: h6.

Manufacturer Narrative

The reported events of noise and lead could not fit into the is-4 connector sleeve were confirmed.As received, a complete lead returned without the connector sleeve.Examination of the lead found the connector boot appeared to be larger in one area.Insertion test confirmed that the lead could not be fully inserted into the test is-4 connector sleeve.Dimensional analysis found the outer diameter of the connector boot was out of product specification at one location.This may have contributed to the reported field events.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• 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: 12664861
• MDR Text Key: 277374665
• Report Number: 2017865-2021-34167
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/65
• Device Catalogue Number: 7122Q-65
• Device Lot Number: A000111074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• 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: 06/11/2021
• 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
• Patient Age: 61 YR
• Patient Sex: Male