MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE LEAD

Model Number	0266
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that over the past year, the right ventricular (rv) lead has been exhibiting a gradual increase in pace impedances.These pace impedance measurements are high and out of range for this lead.The other rv lead measurements were stable and within normal range, including the shock impedance.A nips study was performed and the device is performing as programmed.Technical services was consulted and recommended programming changes.Technical services discussed there may be calcification only on the tip of the lead and not the coil, which is why you would see no changes in the shock impedance.At this time, the lead remains in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9924768
• Report Number: 2124215-2020-04939
• Device Sequence Number: 14291579
• Product Code: NVY
• UDI-Device Identifier: 00802526431296
• UDI-Public: 00802526431296
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: Lay User/Patient
• Device Expiration Date: 08/26/2016
• Device Model Number: 0266
• Device Catalogue Number: 0266
• Device Lot Number: 100900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 04/03/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR