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

Model Number 7122/65

Device Problems Break (1069); Low impedance (2285); Low Sensing Threshold (2575); High Capture Threshold (3266)

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

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an in-clinic follow up, high capture threshold, low sensing threshold, and low pacing impedance were noted on the right ventricular (rv) lead.It is suspected that the cause of the event was due to lead insulation damage.The rv lead was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

The reported event of insulation damage was confirmed, but the reported events of high capture threshold, decreased sensing threshold and low pacing lead impedance were not confirmed.As received, a complete lead was returned in one piece.Electrical and x-ray examinations of the lead did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead found electrocautery damage at the proximal region of the lead.The cause of the reported event of insulation damage is consistent with procedural damage.

• 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: 10140755
• MDR Text Key: 194755603
• Report Number: 2938836-2020-06661
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: 4904908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR