MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4513

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291)

Patient Problems Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead was fractured.The lead was not replaced due to concerns with the global pandemic; however, the patient later began having congestive heart failure symptoms.Therefore, the patient would be scheduled for a lead revision.No additional adverse patient effects were reported.The lead remains in service at this time.

Event Description

It was reported that this left ventricular (lv) lead was fractured.The lead was not replaced due to concerns with the global pandemic; however, the patient later began having congestive heart failure symptoms.Therefore, the patient would be scheduled for a lead revision.No additional adverse patient effects were reported.The lead remains in service at this time.Additional information was received which reported that this lv lead also exhibited impedance measurements of greater than 3000 ohms and loss of capture.The patient had worsening heart failure (as previously reported) along with ventricular tachycardia (vt).The lead was therefore surgically abandoned and replaced.No additional adverse patient effects were reported.

• Brand Name: NA
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12620291
• MDR Text Key: 276360902
• Report Number: 2124215-2021-22686
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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: 04/23/2006
• Device Model Number: 4513
• Device Catalogue Number: 4513
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR