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 Retraction Problem (1536); Inappropriate/Inadequate Shock/Stimulation (1574); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 05/04/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow up.Device interrogation revealed inappropriate shock due to dislodgement during repositioning failure to extent was also noted on the right ventricular (rv) lead.The physician elected to explant and replace the rv lead.The patient was in stable condition.

Event Description

New information notes that the right ventricular lead exhibited high capture thresholds and r wave amplitude variation while the lead was dislodged.

Manufacturer Narrative

The reported event of helix mechanism issue was confirmed while the reported events of high pacing threshold and r wave amp variation were not confirmed.As received, a complete lead was returned in one piece with lead helix partially extended clogged with blood/tissue.After cleaning blood/tissue from the helix and applying torque to the connector pin, the helix could be fully extended and retracted.The full measured helix extension length was within specification.Electrical tests and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies.The cause of the reported event of helix mechanism issue as isolated to the helix being clogged with blood/tissue.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16994382
• MDR Text Key: 315862273
• Report Number: 2017865-2023-20935
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

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/65
• Device Catalogue Number: 7122Q-65
• Device Lot Number: A000130776
• 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: 05/04/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/19/2023; 06/08/2023
• Supplement Dates FDA Received: 06/01/2023; 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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