MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEVICE

Model Number G151

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540)

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

Event Date 01/12/2017

Event Type  malfunction  

Event Description

Boston scientific received information that the remote home monitoring system issued an alert for high out of range shock impedance measurements ranging from 130 to 140 ohms for the cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead.Boston scientific technical services (ts) was consulted and discussed that this lead is a single coil lead which may yield higher impedance measurements.Ts also discussed options for further evaluation of the lead's and system's integrity.At this time the physician has opted to continue to monitor the patient and the rv lead and crt-d remain in service.No adverse patient effects have been reported.Additional information was received that the remote home monitoring system showed remote monitoring had been disabled.It was noted that the cardiac resynchronization therapy defibrillator (crt-d) had reached explant two months earlier.Boston scientific technical services (ts) discussed that once explant is reached the device only has one and a half hours of rf telemetry as per design.It was also noted that the high voltage shock impedances continue to be greater than 125 ohms.During the procedure the crt-d was explanted, and the rv lead remained in service with shock impedance measurements of 90 ohms.No adverse patient effects were reported.Additional information was received which reported there was a high shock lead impedance detected when attempting to deliver a shock.The first shock measured 80 ohms and the second shock was greater than 125 ohms.Shocks three-five impedances measured in the low 100's.It was noted that all therapy was delivered.It was noted that a fc1005 will be observed on an interrogation.Technical services recommended replacing the lead.At this time, the system remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19087544
• MDR Text Key: 340453726
• Report Number: 2124215-2024-22072
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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: 12/15/2018
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 119485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• 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: 63 YR
• Patient Sex: Male