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

Model Number	0262
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this recently implanted right ventricular (rv) defibrillation lead exhibited loss of capture at the pre-discharge check, however normal impedance and r-wave measurements were observed.It was noted that all lead parameters were stable at implant and within normal limits before and after it was connected to the other manufacturer's implantable cardioverter defibrillator (icd).Fluoroscopic imaging confirmed there was no lead dislodgement.The day after implant, this rv lead was explanted and replaced successfully.It was noted that during the lead revision procedure, the rv lead was tested with a pacing system analyzer (psa) and, again, there was normal sensing and pace impedance measurements with no capture.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this recently implanted right ventricular (rv) defibrillation lead exhibited loss of capture at the pre-discharge check, however normal impedance and r-wave measurements were observed.It was noted that all lead parameters were stable at implant and within normal limits before and after it was connected to the other manufacturer's implantable cardioverter defibrillator (icd).Fluoroscopic imaging confirmed there was no lead dislodgement.The day after implant, this rv lead was explanted and replaced successfully.It was noted that during the lead revision procedure, the rv lead was tested with a pacing system analyzer (psa) and, again, there was normal sensing and pace impedance measurements with no capture.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies other than a cut/cuts in the outer insulation, likely due to explant damage.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observation of failure-to-capture.

• 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
• MDR Report Key: 12221503
• Report Number: 2124215-2021-20213
• Device Sequence Number: 3112588
• Product Code: LWS
• UDI-Device Identifier: 00802526601828
• UDI-Public: 00802526601828
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 11/15/2021
• Device Model Number: 0262
• Device Catalogue Number: 0262
• Device Lot Number: 100226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR