MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD DR; IMPLANTABLE DEVICE

Model Number	D013
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a short circuit condition code 1004 after delivery of a shock.The device gave appropriate therapy in which broke the patients arrhythmia however, the right ventricular (rv) shock impedance was low out-of-range (oor).Boston scientific technical services (ts) recommended to replace the device and it was per physician discretion to replace the lead.It was recommended to send the device and lead back for device analysis details once explanted.At this time, the icd and rv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a short circuit condition code 1004 after delivery of a shock.The device gave appropriate therapy in which broke the patients arrhythmia however, the right ventricular (rv) shock impedance was low out-of-range (oor).Boston scientific technical services (ts) recommended to replace the device and it was per physician discretion to replace the lead.It was recommended to send the device and lead back for device analysis details once explanted.At this time, the icd and rv lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received that indicated that this implantable cardioverter defibrillator (icd) was explanted and replaced with a different manufacture's device.The right ventricular (rv) lead remains in service at this time.No additional adverse patient effects were reported.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12112293
• Report Number: 2124215-2021-09647
• Device Sequence Number: 4428910
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2021

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: 07/02/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 102249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 10/10/2021
• 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; Required Intervention
• Patient Age: 77 YR