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

Model Number G154

Device Problems High impedance (1291); Noise, Audible (3273)

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

Event Date 06/19/2021

Event Type  Injury  

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 this cardiac resynchronization therapy defibrillator (crt-d) and implantable right ventricular (rv) defibrillation lead triggered an alert and started beeping due to out-of-range shock impedance measurements greater than 125 ohms.This crt-d and rv lead remain in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and implantable right ventricular (rv) defibrillation lead triggered an alert and started beeping due to out-of-range shock impedance measurements greater than 125 ohms.This crt-d and rv lead remain in service.No adverse patient effects were reported.Additional information received indicated that shock configuration was changed to coil to can, and shock impedance measurements within normal limits were observed.The patient had no arrhythmias or complaints.Patient was non-ischemic.The physician ordered an echo and results were normal.The device was deactivated pending lead revision.This right ventricular (rv) lead was later surgically abandoned and replaced.This cardiac resynchronization therapy defibrillator (crt-d) remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DYNAGEN CRT-D
• 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: 12185214
• MDR Text Key: 262164221
• Report Number: 2124215-2021-19300
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

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: 11/10/2018
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 101784
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 10/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR