MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7120/65

Device Problems Break (1069); Failure to Deliver Shock/Stimulation (1133); Energy Output Problem (1431); Low impedance (2285)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The patient presented in the emergency room following inability of the device to administer high voltage therapy.It was suspected that the cause of the event was due to lead damage causing insulation breach.However, no diagnostic imaging was conducted to confirm the alleged cause.The device was deactivated and the patient will continue to be monitored.The patient was stable.

Manufacturer Narrative

Additional / corrected information.

Event Description

The patient presented in the emergency room following the inability of the device to administer high voltage therapy due to low defibrillation impedance on the right ventricular (rv) lead.It was suspected that the cause of the event was due to lead insulation damage causing insulation breach.However, no diagnostic imaging was conducted to confirm the alleged cause.The device was deactivated and the patient will continue to be monitored.The patient was stable.

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.Additional information: b5, d7, and h10.

Event Description

Additional information received indicating that the right ventricular lead was explanted and replaced to resolve the event.There were no known patient consequences.

Event Description

The patient presented in the emergency room following the inability of the device to administer high voltage therapy due to low defibrillation impedance on the right ventricular (rv) lead.It was suspected that the cause of the event was due to lead insulation damage causing insulation breach.However, no diagnostic imaging was conducted to confirm the alleged cause.The device was initially deactivated and subsequently, the rv lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events of insulation abrasion and low shock impedance were confirmed.As received, a complete lead was returned in two pieces.During electrical testing a short was noted.Destructive analysis was performed and visual inspection found internal abrasion breaching the right ventricular cable lumen to the inner coil lumen proximal to the suture sleeve tie impression.The (ethylene tetrafluoroethylene) etfe cable coating of one right ventricular cable and polytetrafluoroethylene (ptfe) liner of the inner coil were also abraded in this location.The cause of the reported event of low shock impedance was isolated to the internal insulation abrasion to the ptfe liner and the one right ventricular etfe cable coating.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 11036795
• MDR Text Key: 222310165
• Report Number: 2938836-2020-09760
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: 05414734502092
• 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,Followup,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Model Number: 7120/65
• Device Catalogue Number: 7120-65
• Device Lot Number: 2921134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention