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

Model Number	0285
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in the pacing impedance measurement, reaching high out of range values.There is also a slight increase in the pacing threshold observed.Further review by technical services (ts) indicated that performing troubleshooting steps is recommended and to use high output pacing for 5 to 10 minutes and re-evaluate the lead impedance.Upon troubleshooting and high output pacing, the pacing impedance was observed to decrease to values within normal range, indicating that ionization could be the cause of the gradual increase in the pacing impedance.It was also noted that the device oversensed the t-wave during high output pacing.The patient will continue to be monitored.The rv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in the pacing impedance measurement, reaching high out of range values.There is also a slight increase in the pacing threshold observed.Further review by technical services (ts) indicated that performing troubleshooting steps is recommended and to use high output pacing for 5 to 10 minutes and re-evaluate the lead impedance.Upon troubleshooting and high output pacing, the pacing impedance was observed to decrease to values within normal range, indicating that ionization could be the cause of the gradual increase in the pacing impedance.It was also noted that the device oversensed the t-wave during high output pacing.The patient will continue to be monitored.Additional information provided indicates the t-wave oversensing was not able to be reproduced, so device re-programming was not performed by the clinic.In addition, the patient x-rays have been reviewed by the physician and no signs of lead impairment were observed.The rv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in the pacing impedance measurement, reaching high out of range values.There is also a slight increase in the pacing threshold observed.Further review by technical services (ts) indicated that performing troubleshooting steps is recommended and to use high output pacing for 5 to 10 minutes and re-evaluate the lead impedance.Upon troubleshooting and high output pacing, the pacing impedance was observed to decrease to values within normal range, indicating that ionization could be the cause of the gradual increase in the pacing impedance.It was also noted that the device oversensed the t-wave during high output pacing.The patient will continue to be monitored.Additional information provided indicates the t-wave oversensing was not able to be reproduced, so device re-programming was not performed by the clinic.In addition, the patient x-rays have been reviewed by the physician and no signs of lead impairment were observed.The rv lead remains in service.No adverse patient effects were reported.In-clinic troubleshooting was performed and it was observed that the r-wave and shock impedance remains stable.The capture threshold was noted to increase.Provocation testing and pocket manipulation were performed and noise was seen on the rv channel, although it was low level noise and it was not sensed by the device.High output pacing was repeated and the pacing impedance was noted to decrease to normal values.In addition, the patient complained of a nipping feeling at the device site since implant.After the troubleshooting it is confirmed by the clinic that there is a lead issue and lead revision was recommended, however, there is no scheduled date at this time.Ts and engineering review of the device data confirmed the clinical observations point to a potential lead impairment.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a gradual increase in the pacing impedance measurement, reaching high out of range values.There is also a slight increase in the pacing threshold observed.Further review by technical services (ts) indicated that performing troubleshooting steps is recommended and to use high output pacing for 5 to 10 minutes and re-evaluate the lead impedance.Upon troubleshooting and high output pacing, the pacing impedance was observed to decrease to values within normal range, indicating that ionization could be the cause of the gradual increase in the pacing impedance.It was also noted that the device oversensed the t-wave during high output pacing.The patient will continue to be monitored.Additional information provided indicates the t-wave oversensing was not able to be reproduced, so device re-programming was not performed by the clinic.In addition, the patient x-rays have been reviewed by the physician and no signs of lead impairment were observed.The rv lead remains in service.No adverse patient effects were reported.In-clinic troubleshooting was performed and it was observed that the r-wave and shock impedance remains stable.The capture threshold was noted to increase.Provocation testing and pocket manipulation were performed and noise was seen on the rv channel, although it was low level noise and it was not sensed by the device.High output pacing was repeated and the pacing impedance was noted to decrease to normal values.In addition, the patient complained of a nipping feeling at the device site since implant.After the troubleshooting it is confirmed by the clinic that there is a lead issue and lead revision was recommended, however, there is no scheduled date at this time.Ts and engineering review of the device data confirmed the clinical observations point to a potential lead impairment.Additional information provided indicates the rv lead was surgically abandoned and replaced.The implantable cardioverter defibrillator (icd) device was explanted and replaced in the same surgical intervention due to physician discretion and implant an extended longevity device.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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15983246
• Report Number: 2124215-2022-52781
• Device Sequence Number: 14923628
• Product Code: NVY
• UDI-Device Identifier: 00802526431401
• UDI-Public: 00802526431401
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: UK
• PMA/510(K) Number: P910073/S077
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2017
• Device Model Number: 0285
• Device Catalogue Number: 0285
• Device Lot Number: 317990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 03/07/2023; 05/11/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 12/20/2022; 03/29/2023; 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown