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

Model Number	LDA230Q/65
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Related manufacturer reference number: 2017865-2021-32684.It was reported that a patient presented to the clinic on (b)(6) 2021 with noise on their right atrial lead, as well as noise that resulted in oversensing on their right ventricular lead.Both leads were explanted and replaced on (b)(6) 2021.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of noise was confirmed.As received, a partial lead (distal end) was returned in one piece.Final analysis found that the insulation was abraded breaching the ring electrode cable lumen underneath the right ventricular shock coil at 6.4cm to 6.7cm from the distal tip.Final analysis also found that the insulation was abraded breaching the ring electrode cable lumen at 5.3cm to 6.7cm from the distal tip.The ethylene tetrafluoroethylene (etfe) cable coading of one ring electrode cable was abraded in this location as well.The cause of the reported event was isolated to the abrasion of the ring electrode etfe cable coating.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• MDR Report Key: 12601131
• Report Number: 2017865-2021-32683
• Device Sequence Number: 4185693
• Product Code: NVY
• UDI-Device Identifier: 05414734507394
• UDI-Public: 05414734507394
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: LDA230Q/65
• Device Catalogue Number: LDA230Q-65
• Device Lot Number: 4560908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR