MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD

Model Number	7171/65
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Over-Sensing (1438)
Health Effect - Clinical Codes	Death (1802); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Death
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
During a follow-up in-clinic, noise resulting in oversensing was observed on the right ventricular (rv) lead.Surgical intervention is anticipated.The patient was stable with no adverse consequences.
Event or Problem Description
New information notes that surgical intervention was performed to resolve the rv lead noise, and insulation abrasion was noted on the lead upon visual inspection.During the procedure, the patient expired due to a vessel laceration.The physician does not allege the death was due to a lead malfunction, but rather a procedural complication.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8680363
• Report Number: 2938836-2019-04544
• Device Sequence Number: 19400150
• Product Code: LWS
• UDI-Device Identifier: 05414734502443
• UDI-Public: 05414734502443
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 04/01/2012
• Device Model Number: 7171/65
• Device Lot Number: 2915210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: Death