MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q/58

Device Problems Retraction Problem (1536); Use of Device Problem (1670); Low impedance (2285); Failure to Advance (2524); Capturing Problem (2891)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

During an unrelated procedure, it was observed the pacing impedance decreased in range and the capture threshold increased in a non-pacemaker dependent patient on the right ventricular (rv) lead.X-ray imaging was performed and revealed lack of lead slack.The physician alleged the abnormal electrical values were due to lack of lead slack.The physician then attempted to advance a stylet in the rv lead but was not successful.The rv leads helix was attempted to be retracted to reposition the lead but was not successful.The event was resolved by explanting and replacing the rv lead during the unrelated procedure.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, lead slack issue, low pacing lead impedance, inadequate capture threshold, stylet failure to advance, and helix mechanism issue.A complete lead, without a stylet, was returned in one piece for analysis.The reported event of stylet failure to advance was confirmed.X-ray examination found over-torque of the inner coil at the connector region consistent with procedural damage.The cause of the damaged inner coil is consistent with procedural damage.The reported event of helix mechanism issue was confirmed.Visual inspection found the helix fully extended and clogged with dried blood.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 helix extension length met specification.The cause of helix mechanism issue was isolated to dried blood in the helix region, blood on the inner coil, and over-torqued of the inner coil.The reported events of low pacing lead impedance and inadequate capture threshold were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examination of the lead did not find any anomalies except for procedural damage.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18181655
• MDR Text Key: 328633829
• Report Number: 2017865-2023-72831
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: EI
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 7122Q/58
• Device Lot Number: A000106927
• 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: 11/20/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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