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

Model Number 7122Q/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Over-Sensing (1438); Retraction Problem (1536); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)

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

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that a patient presented in-clinic for a lead revision procedure.Prior examination of the patient's right ventricular (rv) lead revealed over-sensing of noise resulting in inappropriate shock.X-ray imaging was used to confirm rv lead dislodgement.During the procedure, the lead helix was unable to be extended or retracted.The rv lead was explanted and replaced on (b)(6) 2023.The patient was stable throughout.

Manufacturer Narrative

The reported events were lead dislodgement, oversensing noise, inappropriate shock, and helix mechanism issue.As received, a complete lead was returned in one piece for analysis.The reported events of oversensing noise and inappropriate shock were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead body did not find any anomalies.X-ray examination found the inner coil over-torqued at the connector region consistent with procedural damage.The reported event of helix mechanism issue was confirmed.Visual inspection found the helix to be retracted and clogged with blood.After cutting the lead and cleaning the distal portion of the lead, the helix could be extended and retracted by applying torque directly to the inner coil.The measured full helix extension length was within specification.The cause of helix mechanism issue was isolated to the helix clogged with blood, blood on the inner coil, and over-torque of the inner coil.

• 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: 16812916
• MDR Text Key: 313986211
• Report Number: 2017865-2023-18422
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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 Catalogue Number: 7122Q-58
• Device Lot Number: A000129689
• 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: 04/06/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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