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

Model Number	0182
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.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 this cardiac resynchronization therapy defibrillator (crt-d) device and right ventricular (rv) lead, exhibited high out of range shock impedance of 127 ohms.The physician advised they believe it may be due to a recent medication change.A technical service (t/s) consultant reviewed the data from the home monitor, noting a gradual increase of out of range shock impedance since (b)(6) 2020 of 104 ohms to 127 ohms.T/s recommended lead integrity testing , but advised may be due to patient condition.The device remains implanted.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• 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: 11104633
• Report Number: 2124215-2020-26997
• Device Sequence Number: 14351395
• Product Code: LWS
• UDI-Device Identifier: 00802526531163
• UDI-Public: 00802526531163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2021

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: 12/15/2012
• Device Model Number: 0182
• Device Catalogue Number: 0182
• Device Lot Number: 300324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 01/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other