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	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Codes	Dizziness (2194); Discomfort (2330); Cardiac Perforation (2513)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is registered as a combination product.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
It was reported that the patient received an implantable cardioverter-defibrillator system implant on (b)(6) 2020.Upon device interrogation prior to discharge, the right ventricular (rv) lead impedance increased.At implant, the impedance was within normal limits.The rv lead impedance further increased when the patient laid down.The rv threshold was noted to also risen.The high voltage lead impedance was normal.The patient reportedly experienced a headache and pocket tenderness.X-ray testing was reviewed and the anteroposterior (ap) view appeared to be unchanged from the post-implant x-ray.The lateral view from the pre-discharge x-ray showed the lead to be pointing anterior in the rv.The physician suspected micro-perforation.A 2d echo was ordered, and nothing definitive was found.The physician was unsure whether micro-perforation occurred.Programming changes were also made to alleviate the risk of the patient receiving a vibratory alert for lead impedance prior to a scheduled lead revision procedure.During the procedure, the physician felt a little resistance when pulling the lead, lead, but he didn't know if that was because it was through the tissue, or just embedded in the tissue.The rv lead was successfully removed and replaced on (b)(6) 2020.The patient was stable.
Additional Manufacturer Narrative
As received, a complete lead was returned in one piece.The reported events of unacceptable threshold and high pacing impedance were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.A tip stiffness test was performed, and the results were within specification.Visual and x-ray inspections of the lead did not find any anomalies.All tines were intact and undamaged.

• 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: 10483055
• Report Number: 2017865-2020-12944
• Device Sequence Number: 19801531
• Product Code: NVY
• UDI-Device Identifier: 05414734507455
• UDI-Public: 05414734507455
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

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: 01/31/2021
• Device Model Number: LDP220Q/65
• Device Catalogue Number: LDP220Q-65
• Device Lot Number: A000091959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 12/18/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/20/2020; 12/21/2020
• 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
• Patient Age: 56 YR