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

Model Number	LDA220/65
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Dizziness (2194); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
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 the patient presented for a follow up in clinic.It was noted that intermittent atrial oversensing resulting in false atrial tachycardia detections was present on the atrial lead.An old alert indicating the defibrillation impedance was above the normal limit was also observed on the right ventricular lead although when tested, defibrillation lead impedance was within normal limits.The patient's vitals were within normal limits and stable.There were no plans for an intervention.
Event or Problem Description
New information notes the patient presented for a routine check in clinic with complaints of dizziness in her own intrinsic rhythm.The complaint was unclear but appeared not to be device related.Defibrillation impedance was intermittently high.The physician was notified but no programming changes were made and there were no plans for an intervention.

• Brand Name: OPTISURE ACTIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8389030
• Report Number: 2017865-2019-03242
• Device Sequence Number: 11134508
• Product Code: NVY
• UDI-Device Identifier: 05414734507202
• UDI-Public: 05414734507202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: LDA220/65
• Device Lot Number: S000004171
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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: 1488TC/58, (B)(4).
• Patient Age: 43 YR