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

Model Number 0292

Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); High Capture Threshold (3266)

Patient Problem Electric Shock (2554)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) system received three inappropriate shocks and six anti-tachycardia pacing (atp) during an episode of atrial driven arrhythmia.Health care professional (hcp) consulted technical services (ts) who recommended reprogramming options.Later, there was a ventricular episode where atp was delivered due to oversensing of the right atrial (ra) lead signal on the ventricular channel.Ts analyzed device data and found that the rv output had increased to 6.5v.It was also noted that there were more rhythmiq episodes than expected due to device optimization.No additional adverse patient effects were reported.Currently, the lead remains in service.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) system received three inappropriate shocks and six anti-tachycardia pacing (atp) during an episode of atrial driven arrhythmia.Health care professional (hcp) consulted technical services (ts) who recommended reprogramming options.Later, there was a ventricular episode where atp was delivered due to oversensing of the right atrial (ra) lead signal on the ventricular channel.Ts analyzed device data and found that the rv output had increased to 6.5v.It was also noted that there were more rhythmiq episodes than expected due to device optimization.No additional adverse patient effects were reported.Currently, the lead remains in service.According to additional information, this lead was surgically abandoned due to the aforementioned inappropriate shocks and high pacing thresholds.A new rv lead was successfully placed.No additional adverse patient effects were reported.According to additional information, a few days prior to procedure, there was an alert for shock into open circuit during an electric shock.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) system received three inappropriate shocks and six anti-tachycardia pacing (atp) during an episode of atrial driven arrhythmia.Health care professional (hcp) consulted technical services (ts) who recommended reprogramming options.Later, there was a ventricular episode where atp was delivered due to oversensing of the right atrial (ra) lead signal on the ventricular channel.Ts analyzed device data and found that the rv output had increased to 6.5v.It was also noted that there were more rhythmiq episodes than expected due to device optimization.No additional adverse patient effects were reported.Currently, the lead remains in service.According to additional information, this lead was surgically abandoned due to the aforementioned inappropriate shocks and high pacing thresholds.A new rv lead was successfully placed.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: 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: 17684477
• MDR Text Key: 322654332
• Report Number: 2124215-2023-48067
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531248
• UDI-Public: 00802526531248
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/05/2020
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 435257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/02/2023; 09/30/2023
• Supplement Dates FDA Received: 10/04/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female