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

Model Number	D002
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experience syncope and pacing inhibition was noted.The patient was hospitalized.Review of the data was requested.The implantable cardioverter defibrillator (icd) remains in service and no additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient experience syncope and pacing inhibition was noted.The patient was hospitalized.Review of the data was requested.The implantable cardioverter defibrillator (icd) remains in service and no additional adverse patient effects were reported.Additional information was received that boston scientific technical services (ts) reviewed the electrogram (egm) strip and noted oversensing of a far-field signal of the atrial pace causing pacing inhibition.Ts noted that the oversensing could not be ruled out as a potential cause of the patient's syncope.Ts further discussed troubleshooting and programming options.The clinic reprogrammed the icd.The icd remains in service and 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: 12618668
• Report Number: 2124215-2021-21202
• Device Sequence Number: 3191742
• Product Code: LWS
• UDI-Device Identifier: 00802526533747
• UDI-Public: 00802526533747
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 11/05/2020
• Device Model Number: D002
• Device Catalogue Number: D002
• Device Lot Number: 117869
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization