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

Model Number LDA210Q/58

Device Problems Failure to Capture (1081); Retraction Problem (1536); Low impedance (2285); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer report number: 2017865-2023-73053.It was reported that the patient presented for remote follow-up via merlin.Net.A review of the transmission revealed a decrease in pacing impedance and sensing by the both the right ventricular (rv) and right atrial (ra) leads.Additionally, the rv lead failed to capture.A chest x-ray revealed that both the rv and rv leads were slightly dislocated from their initial positions.Programming interventions were made, and the patient was scheduled for lead revision.During the procedure the physician attempted to reposition the rv, however, the helix failed to retract.The rv lead was explanted and replaced.Further information was requested but not received.

Manufacturer Narrative

Additional information: b5 and d6b.

Event Description

New information received notes that the patient was stable post- procedure.

Manufacturer Narrative

The reported events were lead dislodgement, helix mechanism issue, sensing r-wave amplitude variation, and low pacing lead impedance.As received, a complete lead was returned in one piece for analysis.The reported events of sensing r-wave amplitude variation and low lead impedance were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspection of the lead did not find any anomalies except for procedural damage.The reported event of helix mechanism issue was confirmed.The lead was returned with the helix retracted and clogged with dried blood.X-ray examination found over-torque of the inner coil at the connector region consistent with procedural damage.After the lead was cut and the distal portion was cleaned, torque was then applied directly to the inner coil, and the helix could be extended/retracted.The helix extension length measured within specification.The cause of helix mechanism issue was isolated to dried blood in the helix region, blood on the inner coil, excessive blood at the distal coupling assembly, and over-torqued of the inner coil.

• Brand Name: OPTISURE 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: 18193930
• MDR Text Key: 328822267
• Report Number: 2017865-2023-73051
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507325
• UDI-Public: 05414734507325
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 01/26/2024

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: LDA210Q/58
• Device Lot Number: A000144482
• 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: 11/02/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 01/17/2024
• Supplement Dates FDA Received: 12/20/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2023
• 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