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

Model Number	7171Q/65
Medical Device Problem Codes	Low impedance (2285); Charging Problem (2892); Naturally Worn (2988)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/17/2020
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: 2017865-2020-17259.It was reported that the patient presented to the emergency room after receiving three successful shocks for ventricular tachycardia.Device interrogation revealed alerts for a shorted output stage and over current detection.Defibrillation impedance measured below the lower limit.The patient was admitted to the hospital.While awaiting device replacement the patient experienced a slow ventricular tachycardia episode; however, the device was found in backup operation and the patient required external defibrillation.The device was able to be programmed to an appropriate pacing rate.During the replacement procedure the lead was found to have worn insulation where it was coiled under the can.On (b)(6) 2020 the device was explanted and right ventricular lead was capped and replaced.There were no further patient consequences.

• Brand Name: DURATA STS OPTIM 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: 10796595
• Report Number: 2017865-2020-17264
• Device Sequence Number: 19752853
• Product Code: NVY
• UDI-Device Identifier: 05414734503297
• UDI-Public: 05414734503297
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: 11/30/2011
• Device Model Number: 7171Q/65
• Device Catalogue Number: 7171Q-65
• Device Lot Number: 3249485
• 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: 10/19/2020
• Initial Report FDA Received Date: 11/05/2020
• 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 VR, U1.6 SJ4 US
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 79