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

Model Number	G154
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); Asystole (4442)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1005, indicative of an open circuit condition detected during shock delivery due to a high out-of-range shock impedance measurement greater than 125 ohms.Additionally, this device stored signal artifact monitoring (sam) episode which revealed the right ventricular (rv) lead high out of range shock impedance measurement.Right atrial (ra) non physiologic noise was observed which was being oversensed, resulting in pacing inhibition of greater than 2 seconds.Technical services (ts) noted this patient's intrinsic rhythm was coming through.Next, the patient experienced a v-3 event followed by non-sustained ventricular tachycardia (nsvt).Although anti-tachycardia pacing (atp) was attempted, it failed to convert the rhythm, and the device subsequently charged again.Despite the rhythm self-terminating, a shock was delivered due to the previous charge divert.The patient experienced an inappropriate shock (ias) as a result.This system remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Common Device Name: DEFIBRILLATOR
• 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: 20856428
• Report Number: 2124215-2024-76994
• Device Sequence Number: 18268174
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/18/2018
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 101717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 07/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male