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

Model Number	D003
Medical Device Problem Codes	Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Dizziness (2194); Electric Shock (2554)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized after receiving two inappropriate shocks.Noise was seen post shock delivery.Provocation testing was performed with no abnormal measurements.It was also noted that the patient had reported feeling dizzy.An inquiry regarding the case was sent for review to technical services (ts) as possible electromagnetic interference (emi) was suspected.Ts reviewed the episodes and noted that the shock electrogram was pointing towards a fast ventricular rhythm.The device was reprogrammed and remains implanted.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient was hospitalized after receiving two inappropriate shocks.Noise was seen post shock delivery.Provocation testing was performed with no abnormal measurements.It was also noted that the patient had reported feeling dizzy.An inquiry regarding the case was sent for review to technical services (ts) as possible electromagnetic interference (emi) was suspected.Ts reviewed the episodes and noted that the shock electrogram was pointing towards a fast ventricular rhythm.The device was reprogrammed and remains implanted.No adverse patient effects were reported.

• Brand Name: ORIGEN 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
• MDR Report Key: 10311274
• Report Number: 2124215-2020-15139
• Device Sequence Number: 16349876
• Product Code: LWS
• UDI-Device Identifier: 00802526533761
• UDI-Public: 00802526533761
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 01/11/2018
• Device Model Number: D003
• Device Catalogue Number: D003
• Device Lot Number: 246458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR