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

Model Number	D001
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device remains implanted, therefore technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.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 during a routine follow up appointment, that this implantable cardioverter defibrillator device exhibited high, out of range pacing impedance (greater than 3,000 ohms).It was suspected that the right ventricular lead could be fractured.The device remains implanted.No adverse patient effects were reported.
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.
Event or Problem Description
It was reported during a routine follow up appointment, that this implantable cardioverter defibrillator device exhibited high, out of range pacing impedance (greater than 3,000 ohms).It was suspected that the right ventricular lead could be fractured.The device remains implanted.No adverse patient effects were reported.A technical service (t/s) consultant reviewed the device data and recommended lead integrity testing by performing arm maneuvers and manipulation.T/s also recommends following the patient closely over the home monitor equipment.

• Brand Name: ORIGEN MINI 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: 11232921
• Report Number: 2124215-2021-02164
• Device Sequence Number: 11603056
• 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 Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 04/21/2020
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 108368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/20/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other