MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	4524
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that pacing lead impedance measurements on this left ventricular (lv) lead, which were 500 ohms at implant and were currently approximately 300 ohms, had dropped below 200 ohms one time.This measurement was not reproducible.Thresholds and sensing measurements were within normal limits and no noise was present.A boston scientific technical services (ts) recommended monitoring.No adverse patient effects were reported.This lead remains in service.

• Brand Name: EASYTRAK 3
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8584567
• Report Number: 2124215-2019-09201
• Device Sequence Number: 2319256
• Product Code: NIK
• UDI-Device Identifier: 00802526353758
• UDI-Public: 00802526353758
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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: Lay User/Patient
• Device Expiration Date: 09/27/2009
• Device Model Number: 4524
• Device Catalogue Number: 4524
• Device Lot Number: 162355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR