MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0286

Device Problem High impedance (1291)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that boston scientific technical services was contacted for a discussion regarding the elevated, out-of-range pacing impedance measurements (>3000 ohms) and loss of capture from this right atrial (ra) lead.During the data review, out-of-range right ventricular (rv) lead pacing impedance measurements (>3000 ohms) were also observed.As the patient is not pacemaker dependent, the physician elected to reprogram the device sensing mode to resolve the event and no adverse patient effects were reported.Both the ra and rv leads remain implanted and in-service.

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 19009030
• MDR Text Key: 339219662
• Report Number: 2124215-2024-19227
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2012
• Device Model Number: 0286
• Device Catalogue Number: 0286
• Device Lot Number: 014618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1