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

Model Number	0171
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned; therefore a 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 during a routine device revision procedure, that this right ventricular rv lead was surgically capped/abandoned (i.E., it remains implanted, but is no longer in service) after exhibiting high, out of range shock impedance (greater than 200 ohms) and noise.The physician determined there to be a lead mechanical issue at the terminal pin.A new lead was implanted.Besides surgical intervention, 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16408734
• Report Number: 2124215-2023-07940
• Device Sequence Number: 6279377
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: 00802526373374
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P910073/S041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

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: 10/01/2009
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 101507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown