MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0672

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Failure to Sense (1559); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced syncopal events while at home.Review of the implantable cardioverter defibrillator (icd) data revealed that the patient was in an ongoing atrial arrhythmia.There were no alerts and the icd was operating as programmed.Further review, however, indicated that there was signal noise on the right ventricular (rv) channel and that the rv pace impedance had sporadic decreases to below 200 ohms.The noise did not appear to be sensed.Technical services recommended further troubleshooting.The rv lead remains in service and no adverse patient effects were reported.

Event Description

It was reported that the patient experienced syncopal events while at home.Review of the implantable cardioverter defibrillator (icd) data revealed that the patient was in an ongoing atrial arrhythmia.There were no alerts and the icd was operating as programmed.Further review, however, indicated that there was signal noise on the right ventricular (rv) channel and that the rv pace impedance had sporadic decreases to below 200 ohms.The noise did not appear to be sensed.Technical services recommended further troubleshooting.The rv lead remains in service and no adverse patient effects were reported.It was additionally reported that the icd recorded a number of ventricular high-rate episodes that appeared to be oversensing of the rv lead noise.Review of the device events indicated the rv noise had been present for some time.Provocative maneuvers/isometrics were not performed as the patient was currently in a high-dependency bed after a possible stroke.The rv lead remains in service.

Event Description

It was reported that the patient experienced syncopal events while at home.Review of the implantable cardioverter defibrillator (icd) data revealed that the patient was in an ongoing atrial arrhythmia.There were no alerts and the icd was operating as programmed.Further review, however, indicated that there was signal noise on the right ventricular (rv) channel and that the rv pace impedance had sporadic decreases to below 200 ohms.The noise did not appear to be sensed.Technical services recommended further troubleshooting.The rv lead remains in service and no adverse patient effects were reported.It was additionally reported that the icd recorded a number of ventricular high-rate episodes that appeared to be oversensing of the rv lead noise.Review of the device events indicated the rv noise had been present for some time.Provocative maneuvers/isometrics were not performed as the patient was currently in a high-dependency bed after a possible stroke.The rv lead remains in service.It was additionally reported that the patient was recently seen for follow-up.Upon interrogation of the icd, it was observed that the rv lead was neither sensing the intrinsic rhythm nor capturing and the pace impedance was less than 200 ohms.Rv lead noise was still being sensed.Leading to storage of tachy episodes.No inappropriate therapy had been delivered.The patient was not pacing dependent and thus was not symptomatic.The therapy was turned off and the patient was admitted to the hospital for urgent lead replacement.The lead was capped and abandoned.A new lead was successfully implanted and no additional adverse patient effects were reported.

Event Description

It was reported that the patient experienced syncopal events while at home.Review of the implantable cardioverter defibrillator (icd) data revealed that the patient was in an ongoing atrial arrhythmia.There were no alerts and the icd was operating as programmed.Further review, however, indicated that there was signal noise on the right ventricular (rv) channel and that the rv pace impedance had sporadic decreases to below 200 ohms.The noise did not appear to be sensed.Technical services recommended further troubleshooting.The rv lead remains in service and no adverse patient effects were reported.It was additionally reported that the icd recorded a number of ventricular high-rate episodes that appeared to be oversensing of the rv lead noise.Review of the device events indicated the rv noise had been present for some time.Provocative maneuvers/isometrics were not performed as the patient was currently in a high-dependency bed after a possible stroke.The rv lead remains in service.It was additionally reported that the patient was recently seen for follow-up.Upon interrogation of the icd, it was observed that the rv lead was neither sensing the intrinsic rhythm nor capturing and the pace impedance was less than 200 ohms.Rv lead noise was still being sensed.Leading to storage of tachy episodes.No inappropriate therapy had been delivered.The patient was not pacing dependent and thus was not symptomatic.The therapy was turned off and the patient was admitted to the hospital for urgent lead replacement.The lead was capped and abandoned.A new lead was successfully implanted, and no additional adverse patient effects were reported.

Manufacturer Narrative

Correction: please refer to additional impact code f23: unexpected medical intervention.

• Brand Name: RELIANCE 4-FRONT
• 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 ; * 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15406528
• MDR Text Key: 300054566
• Report Number: 2124215-2022-35396
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 118671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 08/24/2023; 10/19/2023; 02/12/2024
• Supplement Dates FDA Received: 09/21/2023; 11/01/2023; 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 87 YR