MAUDE Adverse Event Report: ABBOTT OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number LDA210Q/65

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort in the thoracic area.The physician did not consider the discomfort to be clinically significant.Loss of capture and r-wave amplitude variation were noted on the right ventricular (rv) lead due to dislodgement of the lead.A revision procedure was performed to reposition the rv lead, however, the helix of the rv lead was unable to retract.The rv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, loss of capture, sensing r-wave amplitude variation, and helix mechanism issue.As received, a complete lead was returned in one piece for analysis.The reported event of helix mechanism issue was confirmed.Visual inspection found the helix to be partially extended and clogged with blood.X-ray examination found the inner coil to be slightly stretched at the connector region consistent with procedural damage.After cleaning, the helix could be extended and retracted by applying torque to the connector pin.The measured full helix length was within specification.The cause of helix mechanism issue was isolated to the helix being clogged with blood.The reported events of loss of capture and r-wave amplitude variation were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.No anomalies were noted on the lead body at visual inspection.X-ray examination did not find any anomalies except for procedural damage.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16362300
• MDR Text Key: 309382417
• Report Number: 2017865-2023-05734
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: PO
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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: LDA210Q/65
• Device Catalogue Number: LDA210Q-65
• Device Lot Number: A000121810
• 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: 01/24/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• 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
• Treatment: GALLANT VR
• Patient Outcome(s): Required Intervention