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

Model Number	D003
Medical Device Problem Codes	Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Electric Shock (2554); No Code Available (3191)
Date of Event	03/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is expected for analysis but has not been received.
Event or Problem Description
It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) and competitor's right ventricular (rv) lead received multiple inappropriate shocks while at home.The patient was not symptomatic prior to the shocks.After about 10 shocks, the patient was taken by ambulance to the nearest clinic, where the physician on duty did not put a magnet over the device and did not contact boston scientific for assistance.The shocks continued until the battery capacity was depleted.The patient was later transported to another clinic and a device replacement procedure was performed.It was noted the leads were tested with normal measurements observed, and remain implanted with the new device.It was also reported that no save to disk could be performed and the shock episodes could not be reviewed, due to the depleted battery.The explanted device was expected to be returned for laboratory analysis.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) and competitor's right ventricular (rv) lead received multiple inappropriate shocks while at home.The patient was not symptomatic prior to the shocks.After about 10 shocks, the patient was taken by ambulance to the nearest clinic, where the physician on duty did not put a magnet over the device and did not contact boston scientific for assistance.The shocks continued until the battery capacity was depleted.The patient was later transported to another clinic and a device replacement procedure was performed.It was noted the leads were tested with normal measurements observed, and remain implanted with the new device.It was also reported that no save to disk could be performed and the shock episodes could not be reviewed, due to the depleted battery.The explanted device was returned for laboratory analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Patient code 3191 captures the reportable event of surgery.The device is expected for analysis but has not been received.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The review of device memory recorded 194 delivered shocks.Continuous charging of the high voltage capacitors caused the battery to deplete.A review of the associated electrograms showed noise on the right ventricular channel that worsened after shock delivery.Assessment of the noise noted it appeared consistent with either a lead-to-device connection issue or a lead fracture.Each of the setscrews was confirmed to operate as expected and high-powered visual examination confirmed lead seal rings marks that indicated the rv lead was fully inserted in the device header while implanted.Next, a lead was connected to the rv port to conduct further testing.No noise was reproduced when lightly manipulating the lead.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Analysis did not identify any device characteristics that would have caused or contributed to the reported inappropriate shocks.It is possible the currently implanted rv lead has a product performance issue; however, based on the report that testing at the replacement procedure yielded normal measurements this cannot be definitively confirmed.

• 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: 10027643
• Report Number: 2124215-2020-10280
• Device Sequence Number: 2916920
• Product Code: LWS
• UDI-Device Identifier: 00802526533761
• UDI-Public: 00802526533761
• Combination Product (Y/N): N
• Initial Reporter Country: RB
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 02/25/2021
• Device Model Number: D003
• Device Catalogue Number: D003
• Device Lot Number: 252641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention