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

Model Number 7121Q/65

Device Problem Low impedance (2285)

Patient Problem Death (1802)

Event Date 07/02/2018

Event Type  Death  

Event Description

It was reported that a patient received a high voltage shock.After delivery of the shock, the implantable cardioverter defibrillator exhibited low impedance on the right ventricular lead; lead issue was suspected.Manual high voltage impedance test revealed normal range measurements.The patient¿s condition was stable.Later, the device failed to deliver therapy and the patient had entered a vegetative state.The patient died on (b)(6) 2018.

Manufacturer Narrative

External insulation abrasion was noted at 15.2-15.5 cm from the pin consistent with lead friction to the icd can.Internal insulation abrasion under the svc shock coil was noted at 25.5 cm from the distal tip.External insulation abrasion was noted at 15.8-16.2 cm from the distal tip consistent with lead friction to another device or feature of patient anatomy.Internal insulation abrasion under the svc shock coil breaching the right ventricular lumen was noted at 27.2-27.8 cm from the distal tip.The etfe coating was abraded at this location with slight melting of the conductor.This is consistent with the observation from the field of low defibrillation impedance.

Event Description

New information noted that the patient was driving during the time of the event.The patient pulled over and paramedics were called.The paramedics shocked the patient twice, used epinephrine twice, and used bag valve ventilation to transport the patient to the emergency room.Upon arrival at the er, the patient was immediately intubated and transferred to intensive care unit.Treating physicians observed implantable cardioverter defibrillator failure.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7724171
• MDR Text Key: 115155597
• Report Number: 2017865-2018-10910
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503228
• UDI-Public: 05414734503228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: 7121Q/65
• Device Catalogue Number: 7121Q-65
• Device Lot Number: 3408575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Death
• Patient Age: 70 YR