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

Model Number	D002
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was reported to have been physically damaged and had 'cracked' according to a patient advocate.The patient was advised to contact their doctor and the icd remains in service.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: 11233757
• Report Number: 2124215-2021-02231
• Device Sequence Number: 14380663
• Product Code: LWS
• UDI-Device Identifier: 00802526533747
• UDI-Public: 00802526533747
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: 03/06/2020
• Device Model Number: D002
• Device Catalogue Number: D002
• Device Lot Number: 115068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1