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

Model Number	D001
Medical Device Problem Codes	Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Interrogation Problem (4017)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has been returned back from the field for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to have prematurely depleted.The icd was unable to be interrogated as well.Surgical intervention was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to have prematurely depleted.The icd was unable to be interrogated as well.Surgical intervention was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was thoroughly inspected and analyzed.Review of device memory confirmed that the device had reached eri status due to long charge times.Testing confirmed that an internal component was not securely attached to the circuit substrate.This open connection was between a diode component within charging circuitry and the electronics substrate.This incomplete electrical pathway within the device's shock charging circuitry resulted in the lengthened charge times that triggered eri (note that the battery was not depleted, but replacement indicators were triggered because capacitor charging was not accomplished within the specified time).Engineers determined that the conductive epoxy used to connect the diode component to the printed circuit board did not create a secure connection.Despite exhibiting extended charge times, the maximum shock energy was still available and therapy availability is not compromised in devices exhibiting this issue.Therapy would have been available to the patient (if required), albeit with a somewhat longer charge time.This intermittent connection manifests during capacitor reformations or therapy charges.

• 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: 9638248
• Report Number: 2124215-2020-01628
• Device Sequence Number: 13532924
• 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: 2015
• 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): 04/06/2020

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: 09/24/2016
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 438117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention