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

Model Number	0276
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited low out of range pacing impedances measuring below 200 ohms as well as noise on the right ventricular (rv) lead channel.Technical services (ts) was consulted and troubleshooting options were discussed.No adverse patient effects were reported.This system remains in service.
Event or Problem Description
It was reported that the icd system exhibited high out-of-range shock impedance, frequently greater than 200 ohms.Both the rv coil to ra coil and ra coil to can vectors measured greater than 200 ohms, while the rv coil to can configuration measured 60 ohms.It was also noted that the rv lead exhibited noise and frequent low pace impedance measurements of less than 200 ohms.The noise was reproducible on both the rv and shock channels.The icd system was programmed in the rv coil to can configuration and technical services discussed further troubleshooting.No accidents, falls, procedures were known to have occurred that could have influenced the measurements.Additional information received indicated that the patient expired during an rv revision/explant procedure performed on (b)(6) 2024.It was stated that the physician did not feel that the device or procedure contributed to the patient's death; however, no further details were provided.The lead was retained by the facility and is not expected to be returned.

• Brand Name: ENDOTAK RELIANCE
• 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 ; * 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20365132
• Report Number: 2124215-2024-62101
• Device Sequence Number: 12482143
• Product Code: NVY
• UDI-Device Identifier: 00802526531231
• UDI-Public: 00802526531231
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 11/26/2024

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: 08/16/2019
• Device Model Number: 0276
• Device Catalogue Number: 0276
• Device Lot Number: 419452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 08/16/2017
• 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; Death; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male