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

Model Number 7122Q/65

Device Problems Retraction Problem (1536); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Impedance Problem (2950)

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

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that out of range measurements in sensing, capture, and impedance were observed on the right ventricular (rv) lead.Diagnostic imaging was performed and confirmed that the rv lead was dislodged.During revision, the helix of the rv lead failed to extend.The rv lead was capped and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event reported events were lead dislodgement, unacceptable thresholds, sensing anomaly, impedance anomaly and helix mechanism issue.As received, a complete lead was returned in one piece with helix found partially extended and clogged with blood and tissue.The reported event of helix mechanism issue was confirmed.After cleaning, the helix could be extended and retracted by applying torque directly to the connector pin.The full helix extension length was measured within specification.The cause of the reported event of helix mechanism issue was isolated to the helix being clogged with blood/tissue.The reported events of unacceptable threshold, sensing anomaly and impedance anomaly were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: DURATA STS OPTIM 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: 16912210
• MDR Text Key: 315011802
• Report Number: 2017865-2023-19750
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• 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: 06/06/2023

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: S000088121
• 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: 04/14/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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