MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE S; DEFIBRILLATOR / PACEMAKER LEAD

Device Problems Pacing Problem (1439); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Muscle Weakness (1967); Dizziness (2194); Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 03/26/2023

Event Type  malfunction  

Event Description

It was reported that the patient with this unknown endotak right ventricular (rv) lead has had symptoms of dizziness and weakness as well as a recent syncopal episode.It was noted that high pacing thresholds and a gradual decrease in rv lead pacing impedance were observed.The patient has known atrial fibrillation (af) and had an atrioventricular (av) node ablation in the beginning of 2022.The patient is dependent on pacing therapy (100% vp).The device was reprogrammed to vvir mode to avoid potential av crosstalk, and technical services (ts) was consulted for further review.In office lead troubleshooting was recommended.No additional adverse patient effects were reported.

Manufacturer Narrative

This unknown lead remains implanted; therefore, technical analysis cannot be conducted.Without a returned product it is not possible to definitively confirm how it may have contributed to the complaint incident.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the patient with this unknown endotak right ventricular (rv) lead has had symptoms of dizziness and weakness as well as a recent syncopal episode.It was noted that high pacing thresholds and a gradual decrease in rv lead pacing impedance were observed.The patient has known atrial fibrillation (af) and had an atrioventricular (av) node ablation in the beginning of 2022.The patient is dependent on pacing therapy (100% vp).The device was reprogrammed to vvir mode to avoid potential av crosstalk, and technical services (ts) was consulted for further review.In office lead troubleshooting was recommended.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE S
• Type of Device: DEFIBRILLATOR / PACEMAKER 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: 16717947
• MDR Text Key: 313107643
• Report Number: 2124215-2023-16947
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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