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

Model Number 7122Q/58

Device Problems Retraction Problem (1536); Capturing Problem (2891)

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

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported after implant, a patient's right ventricular (rv) lead presented with a high capture threshold.This was addressed by a separate procedure on (b)(6) 2023, in which the rv lead helix would not retract so the lead was explanted and replaced.Post-procedure the patient was stable.

Manufacturer Narrative

The reported events were inadequate capture and the helix mechanism issue.As received, a complete lead was returned in one piece for analysis.The reported event of inadequate capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of helix mechanism issue was confirmed.Visual inspection of the lead found the helix was fully extended with sign of blood.X-ray inspection found the inner coil over-torque at the connector region consistent with procedural damage.After cleaning, the helix was able to be retracted and extended when torque applied directly to the inner coil.The measured full helix extension length was within product specification.The cause of the reported event of helix mechanism issue was isolated to the helix being clogged with blood/tissue and over torque of the inner coil.

Manufacturer Narrative

Additional information: d6a - implant date.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 17958647
• MDR Text Key: 325963951
• Report Number: 2017865-2023-50083
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P950022
• 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,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/58
• Device Lot Number: A000139806
• 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: 10/13/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/26/2023; 12/07/2023
• Supplement Dates FDA Received: 10/30/2023; 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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 Outcome(s): Required Intervention