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

Model Number	0285
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) called technical services (ts) with concerns about the patient of this cardiac resynchronization therapy defibrillator (crt-d) system may have received inappropriate a burst of anti-tachycardia pacing (atp) and shock therapy.The hcp noted that device interrogation revealed a code 1005, indicating an open circuit condition.Ts reviewed the stored data and confirmed that patient received inappropriate burst of atp and shock therapy due to atrial driven arrhythmia.The shock therapy was able to convert the arrythmia.Ts also noted that the right ventricular (rv) lead exhibited shock impedances greater than 125 ohms which led to the code 1005 then shock was being delivered.Ts discussed with the hcp and recommended for the rv lead to be replaced.Subsequently, additional information was received that reported that a revision procedure was performed, the rv lead was surgically abandoned and successfully replaced with a new lead.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: 19667927
• Report Number: 2124215-2024-41166
• Device Sequence Number: 15194724
• Product Code: NVY
• UDI-Device Identifier: 00802526431401
• UDI-Public: 00802526431401
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 10/18/2013
• Device Model Number: 0285
• Device Catalogue Number: 0285
• Device Lot Number: 101310
• 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: 06/14/2024
• Initial Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 10/18/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female