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

Model Number	LDA230Q/65
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that excessive noise was noted on the patient's right ventricular (rv) lead.The noise was reproducible and triggered ventricular fibrillation.The patient did not receive shock.Programming changes were made.Couple of days later, the lead was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
External insulation abrasion breaching re cable lumen was noted at 48.5-48.7 cm from the distal tip consistent with lead friction to the device can.The etfe coating was abraded at this location.This is consistent with the observation from the field of noise oversensing.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10722616
• Report Number: 2938836-2020-08863
• Device Sequence Number: 19669421
• Product Code: NVY
• UDI-Device Identifier: 05414734507394
• UDI-Public: 05414734507394
• 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: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: LDA230Q/65
• Device Catalogue Number: LDA230Q-65
• Device Lot Number: 4602647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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