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

Model Number	D002
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device reached a status of premature battery depletion, indicative of battery voltage too low for the projected remaining capacity, prior to implant.The device was not implanted.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.An evaluation of the device was performed a low/cold temperature, which is expected to result in longer-than-normal charge times.These long charge times led to the subsequent device declaration of elective replacement indicator battery status as observed clinically.The device passed all diagnostic testing and meets normal specifications.
Event or Problem Description
It was reported that this boxed device was noted to have reached a status of elective replacement indictor (eri) battery status, prior to implant.The device was not used and was returned to boston scientific for analysis.

• 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: 8557706
• Report Number: 2124215-2019-07655
• Device Sequence Number: 16881030
• 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
• 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): 07/20/2019

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: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: D002
• Device Catalogue Number: D002
• Device Lot Number: 112196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention