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

Model Number LDA210Q/58

Device Problems Use of Device Problem (1670); Device Contamination with Body Fluid (2317)

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

Event Date 04/28/2020

Event Type  malfunction  

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 implant procedure, the right ventricular (rv) lead was unable to be implanted.Blood and air were noted in the lumen of the lead.The rv lead was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

As received, a complete lead was returned in two pieces.Visual examination revealed the stylet used at the procedure was stuck inside the two portions.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examination did not reveal any anomalies with the exception of procedural damage.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10058242
• MDR Text Key: 191030110
• Report Number: 2938836-2020-03030
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507325
• UDI-Public: 05414734507325
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: LDA210Q/58
• Device Catalogue Number: LDA210Q-58
• Device Lot Number: A000090686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR