MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D023
Medical Device Problem Codes	Signal Artifact/Noise (1036); Pacing Problem (1439); Impedance Problem (2950)
Health Effect - Clinical Codes	Fatigue (1849); Asystole (4442)
Date of Event	10/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) was checked on the emergency room (er) due to feeling fatigued.Upon reviewed, it was found that the device exhibited pacing inhibition with asystole of more than two seconds, due to noisy signals on the non boston scientific right ventricular (rv) lead.Subsequently the device was turned off.The field representative requested confirmation from technical services (ts) to turn on the device.Technical services (ts) reviewed the episodes and found out the rv lead also exhibited high impedances out of range.Ts did not recommend turning the icd on as this could put the patient at risk for inappropriate therapy and more inhibition of pacing from noise.This icd remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 15725728
• Report Number: 2124215-2022-45325
• Device Sequence Number: 14202015
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: 00802526533921
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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: 09/15/2019
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 249942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2017
• 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: 81 YR
• Patient Sex: Female