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

Model Number	LDA220Q/52
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	08/23/2020
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
Related manufacturer reference number: 2017865-2020-13527, 2017865-2020-13528.It was reported the patient presented remotely.Upon review of the transmission, it was observed the implantable cardioverter defibrillator inappropriately delivered anti-tachycardia pacing therapy as a result of incorrect interpretation of rhythm and failed to deliver shock due to the low impedance.The patient presented to the emergency room where it was observed the right ventricular lead and atrial lead had lead abrasion leading to over-sensing noise, as well as low defibrillation impedance on the ventricular lead.The right ventricular lead was capped and replaced on (b)(6) 2020 and the atrial lead had been surgically adhered to address the abrasion.The patient was stable.

• Brand Name: OPTISURE ACTIVE 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: 10528693
• Report Number: 2017865-2020-13526
• Device Sequence Number: 19503034
• Product Code: NVY
• UDI-Device Identifier: 05414734507349
• UDI-Public: 05414734507349
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: 05/31/2015
• Device Model Number: LDA220Q/52
• Device Catalogue Number: LDA220Q-52
• Device Lot Number: 4606673
• 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: 08/23/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FORTIFY ASSURA DR ICD, US; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR