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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gradually over the past four years, this right ventricular (rv) lead has exhibited increased, out-of-range shock impedance measurements (up to 143 ohms).No evidence of noisy signals nor other sensing issues was present.Boston scientific technical services was contacted and it was discussed that the increased shock impedance was likely the result of patient factors, such as calcification or mineralization.It was recommended to increase the device's shock alert value and continue with remote monitoring.At this time, the rv lead remains implanted and in-service.No adverse patient consequences were reported.
Event or Problem Description
It was reported that gradually over the past four years, this right ventricular (rv) lead has exhibited increased, out-of-range shock impedance measurements (up to 143 ohms).No evidence of noisy signals nor other sensing issues was present.Boston scientific technical services was contacted and it was discussed that the increased shock impedance was likely the result of patient factors, such as calcification or mineralization.It was recommended to increase the device's shock alert value and continue with remote monitoring.The physician subsequently increased the shock alert limit and is continuing with normal follow-ups.At this time, the rv lead remains implanted and in-service.No adverse patient effects were reported.
Event or Problem Description
It was reported that gradually over the past four years, this right ventricular (rv) lead has exhibited increased, out-of-range shock impedance measurements (up to 143 ohms).No evidence of noisy signals nor other sensing issues was present.Boston scientific technical services (ts) was contacted and it was discussed that the increased shock impedance was likely the result of patient factors, such as calcification or mineralization.Recently, an alert for shock impedance measurement greater than 200 ohms was received.Ts recommended a commanded shock test prior to a potential rv lead revision.At this time, the rv lead remains implanted and in-service.No adverse patient consequences were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12713642
• Report Number: 2124215-2021-30033
• Device Sequence Number: 1506787
• Product Code: LWS
• UDI-Device Identifier: 00802526531200
• UDI-Public: 00802526531200
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• PMA/510(K) Number: P910073/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2023

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: 06/22/2008
• Device Model Number: 0186
• Device Catalogue Number: 0186
• Device Lot Number: 102297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 01/09/2023
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/19/2021; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown