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

Model Number	D002
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.(b)(4).
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) declared end of life (eol) and was in safety mode following abdominal surgery underwent by this patient.During a previous follow up in (b)(6) 2019, the device displayed normal battery depletion.Subsequently, this icd was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) declared end of life (eol) and was in safety mode following abdominal surgery for this patient.During a previous follow up in november 2019, the device displayed normal battery depletion.The device was explanted and successfully replaced.No additional adverse patient effects were reported.This device has been returned and analysis has been completed.This report has been updated with the product investigation results.
Additional Manufacturer Narrative
The returned implantable cardioverter defibrillator (icd) was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.

• 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: 10340876
• Report Number: 2124215-2020-15954
• Device Sequence Number: 3178560
• 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: 2014
• Device Explanted Year: 2020
• 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): 02/21/2021

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: 05/26/2016
• Device Model Number: D002
• Device Catalogue Number: D002
• Device Lot Number: 102009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention