MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0692

Device Problems Fracture (1260); High impedance (1291); High Capture Threshold (3266)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this right ventricular (rv) lead exhibited high out of range pacing impedance of greater than 3000 ohms and high capture threshold.Rv lead fracture was suspected.Additionally, the patient is not pacing dependent.The physician elected to replace and upgrade this implantable cardioverter defibrillator (icd) system to a subcutaneous implantable cardioverter defibrillator (s-icd) system.No additional adverse patient effects were reported.At this time, the product has been returned, investigation will be performed and this report will be updated.

Event Description

It was reported that this right ventricular (rv) lead exhibited high out of range pacing impedance of greater than 3000 ohms and high capture threshold.Rv lead fracture was suspected.Additionally, the patient is not pacing dependent.The physician elected to replace and upgrade this implantable cardioverter defibrillator (icd) system to a subcutaneous implantable cardioverter defibrillator (s-icd) system.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection confirmed setscrew marks on the terminal pin.Resistance testing and x-ray images determined that the distal high voltage cable was fractured approximately 3.5-4 cm from the terminal pin, under the silicone rubber boot that is bonded to the terminal and lead body.Based on the characteristics of the fracture, it was determined that it was consistent with cyclic fatigue damage.The identified cable fracture is the likely root cause of the reported fractured lead.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11237774
• MDR Text Key: 228924708
• Report Number: 2124215-2020-27217
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2019
• Device Model Number: 0692
• Device Catalogue Number: 0692
• Device Lot Number: 533730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention