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

Model Number	LDP220Q/58
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); High Capture Threshold (3266)
Health Effect - Clinical Codes	Syncope (1610); Therapeutic Effects, Unexpected (2099); Shock from Patient Lead(s) (3162)
Date of Event	03/05/2019
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.
Event or Problem Description
It was reported that a patient presented in the emergency room with an implantable cardioverter device (icd) that exhibited episodes of inappropriate shock and anti tachycardia pacing (atp).Patient complained of brief syncope with each episode.Upon review of the patient's electrogram (egm), clinician noted that the patient had atrial fibrillation (a-fib) with rapid ventricular response (rvr), occasionally with aberrancy.Clinician was unclear whether this was ventricular tachycardia (vt) or a-fib with aberrancy due to stable, regular rhythm with different morphology.Clinician also noted elevated pacing threshold in the right ventricular lead.Programming changes were made.Patient was stable after programming.

• 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: 8516503
• Report Number: 2017865-2019-05358
• Device Sequence Number: 1899707
• Product Code: NVY
• UDI-Device Identifier: 05414734507448
• UDI-Public: 05414734507448
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 05/31/2017
• Device Model Number: LDP220Q/58
• Device Lot Number: 4617299
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/15/2019
• 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