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

Model Number 4513

Device Problems Failure to Capture (1081); High impedance (1291); Defective Device (2588); High Capture Threshold (3266)

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

Event Date 10/22/2023

Event Type  malfunction  

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a right ventricular assist device (rvad) implant procedure due to a change in patient's condition via loss of right ventricular (rv) contractility, it was suspected that both the right ventricular (rv) and left ventricular (lv) leads were damaged during the procedure.Pacing spikes were observed on external telemetry, however there was no rv or lv capture at maximum outputs.Additionally, rv and lv pace impedance measurements were greater than 3,000 ohms.The rv lead and lv lead remains in service.No adverse patient effects were reported.

• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18133156
• MDR Text Key: 328072381
• Report Number: 2124215-2023-64019
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2023

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: Health Professional
• Device Expiration Date: 01/16/2005
• Device Model Number: 4513
• Device Catalogue Number: 4513
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2003
• 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: 80 YR
• Patient Sex: Male