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

Model Number G151

Device Problems Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem Electric Shock (2554)

Event Date 11/11/2023

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1004 indicative of a short circuit condition detected during shock delivery, additionally, the device also recorded a code 1006 indicative of high voltage during charge repeat.Analysis of the device was performed and it was found that the device exhibited low out of range shock impedance measurements.Furthermore, oversensing was observed, which led to three inappropriate shocks, the last one was the one suspected to have triggered the codes on the device.Replacement of the system was advised.It was decided to turn the therapy off and schedule a system replacement in the near future.At this time, this device remains in service.No further adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE 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: 18257611
• MDR Text Key: 329618639
• Report Number: 2124215-2023-68472
• 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: Other
• Type of Report: Initial
• Report Date: 12/04/2023

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: 01/24/2024
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 151411
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female