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

Model Number 7122Q/65

Device Problems High impedance (1291); Device Contamination with Body Fluid (2317); Low Sensing Threshold (2575); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a follow-up, increased pacing impedance and decreased sensing were observed on the right ventricular (rv) lead.Provocative testing was performed and the lead impedance and sensing anomalies were reproduced.An x-ray was performed and no anomalies were noted.During the revision procedure, blood and tissue were noted on the lead connector which the physician suspected caused a connection issue with the header.The lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

As received, a complete lead was returned in one piece.Visual and x-ray examination of the lead did not reveal any anomalies.Complete x-ray examination and electrical testing did not reveal any indication of conductor fractures or internal shorts.The lead was able to be fully inserted and removed from the device with no restriction.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10276643
• MDR Text Key: 198895915
• Report Number: 2938836-2020-07363
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 7122Q/65
• Device Catalogue Number: 7122Q-65
• Device Lot Number: S000075966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention