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 Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection noted only the terminal segment of the lead was returned severed approximately 11.2 centimeters from the is-1 terminal pin.A setscrew mark was noted in the correct location on the terminal connector.Testing of was completed to assess the inner insulation of the returned segment.Measurements throughout this test were within normal limits.Analysis was unable to confirm the allegation made against the lead based on the segment that was returned for analysis.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a rise in shock impedance measurements.Surgical intervention was performed and the rv lead was cut and abandoned in the patient.The end of the rv lead will be returned for analysis.No additional 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: 8581428
• Report Number: 2124215-2019-08511
• Device Sequence Number: 1655064
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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: 01/26/2009
• Device Model Number: 0182
• Device Catalogue Number: 0182
• Device Lot Number: 101090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening