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

Model Number 7122/65

Device Problem Low Sensing Threshold (2575)

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

Event Date 07/14/2020

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 an in-clinic follow up, low sensing threshold was noted on the right ventricular (rv) lead.It was suspected that the cause of the event was due to patient-related condition.The rv lead was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

Additional information: d10, h3, and h6.The reported event of low sensing threshold could not be confirmed.As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection and x-ray examination of the lead did not find any anomalies except 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: 10314280
• MDR Text Key: 200059317
• Report Number: 2938836-2020-07499
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: A000008041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention