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

Model Number	7171/65
Medical Device Problem Codes	Break (1069); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that noise leading to oversensing was observed on the low voltage right ventricular (rv) lead, the high voltage rv lead, the left ventricular (lv) lead, and right atrial (ra) lead.Abnormal pacing impedance was also observed on the lv lead.The noise led to inhibition of pacing in a pacing dependent patient.Lead damage was suspected but no diagnostic imaging was performed to confirm lead damage.The noise could be reproduced with provocative testing.The device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.There were no adverse consequences.Related manufacturer related reference number: 2017865-2022-07289, 2017865-2022-07287, 2017865-2022-07286.
Event or Problem Description
It was reported that noise leading to oversensing was observed on the low voltage right ventricular (rv) lead, the high voltage rv lead, the left ventricular (lv) lead, and right atrial (ra) lead.Abnormal pacing impedance was also observed on the lv lead.The noise led to inhibition of pacing in a pacing dependent patient.The noise could be reproduced with provocative testing.The device was reprogrammed to resolve the event.During revision, lead damage due to subclavian crush was confirmed.The high voltage rv lead remains implanted.The patient was stable and will continue to be monitored.There were no adverse consequences.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14030352
• Report Number: 2017865-2022-07288
• Device Sequence Number: 4628768
• Product Code: LWS
• UDI-Device Identifier: 05414734502443
• UDI-Public: 05414734502443
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2022

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: 06/24/2012
• Device Model Number: 7171/65
• Device Catalogue Number: 7171-65
• Device Lot Number: 2915328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/15/2022; 05/09/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/03/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown