MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE PASSIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	LDP220Q/65
Medical Device Problem Codes	Intermittent Capture (1080); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
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.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Was reported that the patient presented to the hospital for an unrelated reason.A device check revealed that the right ventricular lead exhibited increased capture thresholds.The patient was referred for subsequent lead revision.The lead was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
New information received noted that the right ventricular lead was explanted and replaced due to increasing threshold and intermittent loss of capture.The patient was in stable condition.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
Final analysis found that as received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examination of the lead did not find any anomalies.The reported events of inadequate capture and intermittent capture were not confirmed.

• Brand Name: OPTISURE PASSIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9608260
• Report Number: 2017865-2020-00711
• Device Sequence Number: 10888471
• Product Code: NVY
• UDI-Device Identifier: 05414734507455
• UDI-Public: 05414734507455
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2020

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: 05/31/2020
• Device Model Number: LDP220Q/65
• Device Catalogue Number: LDP220Q-65
• Device Lot Number: A000080529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/17/2020; 02/11/2020; 02/25/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/10/2020; 02/11/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention