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

Model Number	D012
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd), presented to the emergency room after getting shocks for sinus tachycardia.Review of a consult transmission exhibited inappropriate anti-tachycardia pacing (atp) due to atrial driven tachycardia episodes, with therapy exhaustion observed in an episode.Technical services (ts) also noted device battery status had reached elective replacement indicator, and recommended replacing device within 90 days.Subsequently, the device was explanted and replaced with a new device.No additional adverse patient effects were reported.At this time, the device has not been returned for analysis.If the device is received, product analysis will be completed, and this report will be updated with pertinent information.

• Brand Name: INOGEN 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: 12662468
• Report Number: 2124215-2021-31557
• Device Sequence Number: 4852056
• Product Code: LWS
• UDI-Device Identifier: 00802526533822
• UDI-Public: 00802526533822
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 08/25/2016
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 104426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR