MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0266
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for analysis.A supplemental report will be filed at the time of completion.
Event or Problem Description
It was reported that this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) system were an attempted implant due to noise as a result of air bubbles.It was noted that the sealing rings appeared to have a hole.Technical services (ts) discussed troubleshooting the air bubbles including burping the device header and checking the sealing rings.The physician however, requested a new device be placed at which point the same phenomenon occurred.The physician then requested a different right ventricular (rv) lead be implanted.That rv lead was connected to the new device and the issues subsided.It was thought that the first rv lead may have been tight near the clavicle however, the lead had measured well.The new icd and rv lead remain in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
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.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 observations.
Event or Problem Description
It was reported that this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) system were an attempted implant due to noise as a result of air bubbles.It was noted that the sealing rings appeared to have a hole.Technical services (ts) discussed troubleshooting the air bubbles including burping the device header and checking the sealing rings.The physician however, requested a new device be placed at which point the same phenomenon occurred.The physician then requested a different right ventricular (rv) lead be implanted.That rv lead was connected to the new device and the issues subsided.It was thought that the first rv lead may have been tight near the clavicle however, the lead had measured well.The new icd and rv lead remain in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 15595877
• Report Number: 2124215-2022-37237
• Device Sequence Number: 19367051
• Product Code: NVY
• UDI-Device Identifier: 00802526431296
• UDI-Public: 00802526431296
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 03/14/2024
• Device Model Number: 0266
• Device Catalogue Number: 0266
• Device Lot Number: 420565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Male