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

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	06/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead had a gradual rise in shock impedance, and were now out of range greater than 125 ohms.The plan appeared to be to continue to monitor at this time, and appeared that they would consider increasing the alert limit to 150 ohms.The lead remains in-service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10237012
• Report Number: 2124215-2020-12270
• Device Sequence Number: 19657573
• Product Code: LWS
• UDI-Device Identifier: 00802526531163
• UDI-Public: 00802526531163
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 06/09/2011
• Device Model Number: 0182
• Device Catalogue Number: 0182
• Device Lot Number: 101427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR