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

Model Number 0293

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285); Defective Device (2588)

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

Event Date 01/16/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited myopotential noise.This noise was reproduced with body movement testing.Technical services (ts) analyzed device episode data and found an episode where there was oversensing of the noise which resulted in one burst of anti-tachycardia pacing (atp) being delivered.An insulation breach was suspected.It was noted that the patient was scheduled for a defibrillation threshold (dft) test because it had not been done during new implant and that increasing the programmed sensitivity would be done.However, it was decided to explant this lead and replace with a new rv lead.No additional adverse patient effects were reported.As of today, this product has not been returned to boston scientific for analysis.Ck.

Event Description

It was reported that this right ventricular (rv) lead exhibited myopotential noise.This noise was reproduced with body movement testing.Technical services (ts) analyzed device episode data and found an episode where there was oversensing of the noise which resulted in one burst of anti-tachycardia pacing (atp) being delivered.An insulation breach was suspected.It was noted that the patient was scheduled for a defibrillation threshold (dft) test because it had not been done during new implant and that increasing the programmed sensitivity would be done.However, it was decided to explant this lead and replace with a new rv lead.No additional adverse patient effects were reported.As of today, this product has not been returned to boston scientific for analysis.According to additional information, this lead exhibited low impedance measurements prior to extraction.

• Brand Name: ENDOTAK RELIANCE SG
• 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: 18978458
• MDR Text Key: 338596506
• Report Number: 2124215-2024-18127
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531255
• UDI-Public: 00802526531255
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2015
• Device Model Number: 0293
• Device Catalogue Number: 0293
• Device Lot Number: 115025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2013
• 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): Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female