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); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system, implanted with another manufacturer's right atrial (ra) and right ventricular (rv) leads, underwent a system revision.High out-of-range pace impedance measurements >3,000 ohms were first detected on the ra channel (b)(6) 2020, and the ra lead was turned off.High out-of-range pace impedance measurements >3,000 ohms were later detected on the rv channel as early as (b)(6) 2022.No noise events were stored since the impedances went out of range, however (v-1) a stored episode back from (b)(6) 2019 had showed some possible emi noise with oversensing.The physician suspected clavicular crush, but it was unclear whether this was for one of both leads.However, technical services (ts) discussed possible spring contact behavior due to lack of recently stored noise events.Additional information received reported that the icd was explanted/replaced with single chamber icd, the leads were surgically abandoned due to lead dislodgement, and the rv lead was replaced.No additional adverse patient effects were reported.
Additional 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.The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system, implanted with another manufacturer's right atrial (ra) and right ventricular (rv) leads, underwent a system revision.High out-of-range pace impedance measurements >3,000 ohms were first detected on the ra channel (b)(6) 2020, and the ra lead was turned off.High out-of-range pace impedance measurements >3,000 ohms were later detected on the rv channel as early as (b)(6) 2022.No noise events were stored since the impedances went out of range, however (v-1) a stored episode back from (b)(6) 2019 had showed some possible emi noise with oversensing.The physician suspected clavicular crush, but it was unclear whether this was for one of both leads.However, technical services (ts) discussed possible spring contact behavior due to lack of recently stored noise events.Additional information received reported that the icd was explanted/replaced with single chamber icd, the leads were surgically abandoned due to lead dislodgement, and the rv lead was replaced.No additional adverse patient effects were reported.Additional information received reported that both the right atrial (ra) and right ventricular (rv) leads had dislodged, per fluoroscopic imaging.The field representative denied clavicular crush.The physician decided to implant a new df4 lead, and the icd was also replaced by a new device with the corresponding header.Both the ra and rv leads were surgically abandoned.It was noted that there were no concerns regarding the explanted icd.Records indicate the icd was returned for analysis.No additional adverse patient effects were reported.
Additional 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.-- the product has been received for analysis.This report will be updated upon completion of analysis.-- the returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system, implanted with another manufacturer's right atrial (ra) and right ventricular (rv) leads, underwent a system revision.High out-of-range pace impedance measurements >3,000 ohms were first detected on the ra channel september 2020, and the ra lead was turned off.High out-of-range pace impedance measurements >3,000 ohms were later detected on the rv channel as early as september 2022.No noise events were stored since the impedances went out of range, however (v-1) a stored episode back from july 2019 had showed some possible emi noise with oversensing.The physician suspected clavicular crush, but it was unclear whether this was for one of both leads.However, technical services (ts) discussed possible spring contact behavior due to lack of recently stored noise events.Additional information received reported that the icd was explanted/replaced with single chamber icd, the leads were surgically abandoned due to lead dislodgement, and the rv lead was replaced.No additional adverse patient effects were reported.Additional information received reported that both the right atrial (ra) and right ventricular (rv) leads had dislodged, per fluoroscopic imaging.The field representative denied clavicular crush.The physician decided to implant a new df4 lead, and the icd was also replaced by a new device with the corresponding header.Both the ra and rv leads were surgically abandoned.It was noted that there were no concerns regarding the explanted icd.Records indicate the icd was returned for analysis.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: 16174813
• Report Number: 2124215-2023-01497
• Device Sequence Number: 11428370
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: 00802526533921
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 250164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 01/26/2023; 02/21/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/16/2023; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female