MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D021
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter-defibrillator (icd) delivered some electric shocks.It was suspected that this patient was in sinus rhythm.Technical services (ts) was consulted and provided troubleshooting suggestions.The icd tried to be interrogated.Unfortunately, it was found that the remote monitoring capabilities had become disabled due to limited battery capacity once the icd reached the end of life (eol).Further review of this icd data revealed that anti-tachycardia pacing (atp) therapy was delivered to convert the arrhythmia.Additionally, out-of-range pacing impedance measurements, out-of-range shock impedance measurements, and noisy signals were also observed.Icd system replacement was recommended.Subsequently, a revision procedure was performed and the icd and the non-boston scientific lead were explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter-defibrillator (icd) delivered some electric shocks.It was suspected that this patient was in sinus rhythm.Technical services (ts) was consulted and provided troubleshooting suggestions.The icd tried to be interrogated.Unfortunately, it was found that the remote monitoring capabilities had become disabled due to limited battery capacity once the icd reached the end of life (eol).Further review of this icd data revealed that anti-tachycardia pacing (atp) therapy was delivered to convert the arrhythmia.Additionally, out-of-range pacing impedance measurements, out-of-range shock impedance measurements, and noisy signals were also observed.Icd system replacement was recommended.Subsequently, a revision procedure was performed and the icd and the non-boston scientific lead were explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, analysis of the returned icd found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: DYNAGEN MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER 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: 15048551
• Report Number: 2124215-2022-26249
• Device Sequence Number: 14831549
• Product Code: LWS
• UDI-Device Identifier: 00802526533884
• UDI-Public: 00802526533884
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/08/2016
• Device Model Number: D021
• Device Catalogue Number: D021
• Device Lot Number: 436017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male