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

Model Number 7122Q/65

Device Problems Retraction Problem (1536); Low impedance (2285); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 10/03/2023

Event Type  Injury  

Event Description

It was reported that the patient presented for a follow up in clinic.It was noted that r waves and pacing lead impedance was low and pacing threshold was high.Rv lead dislodgement was suspected.An attempt to re-position the right ventricular (rv) lead was made.During the repositioning procedure, the rv lead's helix could not be fully retracted.A mechanical problem, difficulty in set up was alleged.A new lead was placed, and the procedure was completed with no issues or adverse patient consequences.

Manufacturer Narrative

The reported events were lead dislodgement, sensing r-wave amplitude variation, inadequate capture threshold, low pacing lead impedance, and helix mechanism issue.As received, a complete lead was returned in one piece for analysis.The reported events of sensing r-wave amplitude variation, inadequate capture threshold, and low pacing lead impedance were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.X-ray examination did not find any anomalies except for procedural damage.Visual inspection of the lead body did not find any additional anomalies.The reported event of helix mechanism issue was confirmed.The lead was returned with the helix fully extended and clogged with dried blood.X-ray inspection found the inner coil over-torqued at the connector region consistent with procedural damage.After cutting the lead, cleaning the distal portion of the lead, and applying torque directly to the inner coil, the helix could be retracted/extended, and the full helix extension length met specification.The cause of helix mechanism issue was isolated to dried blood in the helix region and over-torqued of the inner coil.

• 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: 17960467
• MDR Text Key: 325980627
• Report Number: 2017865-2023-50113
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• Combination Product (y/n): Y
• Reporter Country Code: TH
• 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
• Report Date: 11/08/2023

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 Lot Number: A000120707
• 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: 10/03/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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