MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D400
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this system exhibited jumpy and varying pacing impedance measurements on the right ventricular (rv) channel.A review of the device data identified two red alerts had been generated due to the measurements exceeding 2000 ohms.The patient's system consists of this boston scientific implantable pulse generator (ipg) and a competitive rv lead.A boston scientific technical services consultant discussed potential reasons for the clinical observations and troubleshooting techniques.No adverse patient effects were reported.

• Brand Name: PERCIVA ICD VR
• 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: 11104870
• Report Number: 2124215-2020-26116
• Device Sequence Number: 846295
• Product Code: LWS
• UDI-Device Identifier: 00802526587863
• UDI-Public: 00802526587863
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2021

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: 03/07/2021
• Device Model Number: D400
• Device Catalogue Number: D400
• Device Lot Number: 110025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 01/02/2021
• Patient Sequence Number: 1
• Patient Age: 31 YR