MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D001
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely when the pacemaker reached the elective replacement indicator (eri).High left ventricular (lv) lead threshold were noted, and upon reprogramming the device, the battery improved with one year of battery longevity remaining.Technical services (ts) reviewed the case, and reiterated that longevity is accurate over the service life of the device, but is imprecise nearing explant/eri due to uncertainties and sensitivity to small changes.Disk data was requested to confirm battery longevity.This investigation will be updated when further information is provided.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received.No allegation of premature battery depletion from the field representative or physician.This event was merely intended as an inquiry of device behavior.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely when the pacemaker reached the elective replacement indicator (eri).High left ventricular (lv) lead threshold were noted, and upon reprogramming the device, the battery improved with one year of battery longevity remaining.Technical services (ts) reviewed the case, and reiterated that longevity is accurate over the service life of the device, but is imprecise nearing explant/eri due to uncertainties and sensitivity to small changes.Disk data was requested to confirm battery longevity.This investigation will be updated when further information is provided.No adverse patient effects were reported.Additional information was received from the field representative.There was no allegation of premature battery depletion on this device, but merely an inquiry on device behavior.This pacemaker was subsequently explanted as part of a routine changeout, and no adverse patient effects were reported.

• Brand Name: ORIGEN MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15427830
• Report Number: 2124215-2022-36150
• Device Sequence Number: 20760466
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 03/25/2016
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 435802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown