MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0186
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This lead has not been returned and likely remained implanted.The local area field representative was contacted for additional information.At this time, no further information is available.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient implanted with this defibrillation lead expired.There were no allegations against lead functionality.Review of stored data found high out of range pacing impedance measurements had been observed.The high measurements were intermittent and there was no evidence of noise on the lead.No adverse patient effects were reported related to the out of range impedance measurements.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11227935
• Report Number: 2124215-2021-01921
• Device Sequence Number: 17005816
• Product Code: LWS
• UDI-Device Identifier: 00802526531200
• UDI-Public: 00802526531200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 04/28/2010
• Device Model Number: 0186
• Device Catalogue Number: 0186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR