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

Model Number 0273

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) called with concerns of noisy signals in the right ventricular (rv) channel and requested technical services (ts) review of this cardiac resynchronization therapy defibrillator (crt-d) device stored ventricular episodes.Upon review, the presenting electrogram (egm) showed that the device had delivered a burst of inappropriate anti-tachycardia pacing (atp) and inappropriate shock therapy.It was also noted that the patient had experienced symptoms prior to the shock.Further review revealed that the noise was oversensed and pacing had been inhibited for more than two seconds.Ts determined the oversensed noise seen on the egm may be due to electromagnetic interference (emi).Ts advised the hcp to schedule a visit with the patient for further evaluation.No adverse patient effects were reported.The lead remains in service.

• Brand Name: ENDOTAK RELIANCE
• 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 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18862204
• MDR Text Key: 337556847
• Report Number: 2124215-2024-14251
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526601811
• UDI-Public: 00802526601811
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/10/2023
• Device Model Number: 0273
• Device Catalogue Number: 0273
• Device Lot Number: 115342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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 Age: 53 YR
• Patient Sex: Male