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

Model Number 0185

Device Problems High impedance (1291); Material Integrity Problem (2978)

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

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

Event Description

It was reported that during a routine follow up, this right ventricular (rv) lead exhibited high out of range shock impedance measurements when using the right atrial (ra) and rv shock vector configuration.Additionally, when programming to triad configuration, it was revealed that the ra coil had overall high impedance.The device was reprogrammed with a reported shock impedance of 70 ohms.To ensure appropriate sensing during arrhythmia events, induction of ventricular fibrillation was recommended.At this time, the details of the implanted ra lead are unknown, but additional information was requested to the field.No adverse patient effects were reported.The rv lead remains in service.Additional information provided from the field indicated surgical intervention was later performed and this lead was replaced and abandoned in the patient.It was observed that the lead coil was broken.A new subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.No additional adverse patient effects were reported.

Event Description

It was reported that during a routine follow up, this right ventricular (rv) lead exhibited high out of range shock impedance measurements when using the right atrial (ra) and rv shock vector configuration.Additionally, when programming to triad configuration, it was revealed that the ra coil had overall high impedance.The device was reprogrammed with a reported shock impedance of 70 ohms.To ensure appropriate sensing during arrhythmia events, induction of ventricular fibrillation was recommended.At this time, the details of the implanted ra lead are unknown, but additional information was requested to the field.No adverse patient effects were reported.The rv lead remains in service.Additional information provided from the field indicated surgical intervention was later performed and this lead was replaced and abandoned in the patient.It was observed that the lead coil was broken.A new subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.

• Brand Name: ENDOTAK RELIANCE G
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19035276
• MDR Text Key: 339281462
• Report Number: 2124215-2024-20300
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P910073/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2014
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Device Lot Number: 360621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2012
• 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