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

Model Number	D001
Medical Device Problem Codes	Delayed Charge Time (2586); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this implantable cardioverter defibrillator (icd) declared code 1007, capacitor charge time has exceeded the limit.Subsequently, the patient underwent surgical intervention to have device explanted and replaced.No adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Additional Manufacturer Narrative
A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Visual inspection of the device noted no anomalies.Review of device memory indicated that a charge timeout alert (> 45 seconds) had been recorded.The device case was opened, and visual inspection noted that one of the two high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, and it was concluded that the hv capacitor experienced internal arcing caused by a low resistance pathway between anode and cathode plates within the capacitor.This capacitor issue impacted the device's ability to provide shock therapy because the hv capacitors could not be fully charged, but brady pacing, telemetry, and other device functionality remained available.
Event or Problem Description
It was reported this implantable cardioverter defibrillator (icd) declared code 1007, capacitor charge time has exceeded the limit.Subsequently, the patient underwent surgical intervention to have device explanted and replaced.No adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• Brand Name: ORIGEN MINI ICD VR
• 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: 9549882
• Report Number: 2124215-2019-25179
• Device Sequence Number: 11295955
• Product Code: LWS
• UDI-Device Identifier: 00802526533723
• UDI-Public: 00802526533723
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2020

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: 08/15/2018
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 104845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention