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

Model Number	0185
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedance measurements greater than 135 ohms.It was also noted that the cardiac resynchronization therapy defibrillator (crtd) is at elective replacement indicator (eri) and a changeout was planned.Additionally, no noise could be seen, and rv pace impedance was within normal limits.Technical services (ts) recommended a max energy r wave synch shock and if a code 1005 indicative of an open circuit condition during shock delivery is recorded then lead replacement was recommended, however if after the shock the shocking impedances are within range the physician can consider monitoring the lead.This lead remains in service.No adverse patient effects were reported.Additional information was received, an energy shock to the existing lead was performed and measurements were accepted.The crtd was replaced due to normal battery depletion and this lead remains in service with the new crtd.No additional 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: 19710212
• Report Number: 2124215-2024-42514
• Device Sequence Number: 6964597
• Product Code: LWS
• UDI-Device Identifier: 00802526531194
• UDI-Public: 00802526531194
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 08/28/2017
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Device Lot Number: 367122
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/10/2024
• Date Device Manufactured: 08/28/2015
• 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: Other
• Patient Age: 35 YR
• Patient Sex: Male