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

Model Number	0262
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) exhibited low amplitude and undersensing on the right ventricular (rv) lead.Which led to a delay in the therapy.Subsequently, the rv lead was not successfully implanted.This rv lead was never in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, analysis of the returned lead found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) exhibited low amplitude and undersensing on the right ventricular (rv) lead.Which led to a delay in the therapy.Subsequently, the rv lead was not successfully implanted.This rv lead was never in service and no adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE LEAD
• 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: 15064453
• Report Number: 2124215-2022-26485
• Device Sequence Number: 5504161
• Product Code: LWS
• UDI-Device Identifier: 00802526601828
• UDI-Public: 00802526601828
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 02/10/2024
• Device Model Number: 0262
• Device Catalogue Number: 0262
• Device Lot Number: 100487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female