MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G051

Device Problems Device Alarm System (1012); High impedance (1291)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

This device remains implanted and in service, 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 Description

It was reported that this patient with a implantable cardioverter defibrillator (icd) and non-boston scientific leads was hospitalized in the intensive care unit, due to hemodynamic issues.It is not known if the hemodynamic issues were due to patient condition or related to the device.The hospital does not have a programmer to interrogate the device.The patient reported hearing tones emitting from the device, and right ventricular (rv) lead had high, out of range pacing impedance (greater than 2400 ohms).A technical service (t/s) consultant reviewed device data available from november, reporting that the tones could be related to the high out of range pacing impedance.The patient reported having a mitral clip implanted in (b)(6) 2020.T/s consultant recommended programming options, and recommended having the patient follow up with the primary electrophysiologist for an interrogation of the device, lead integrity testing and x-ray images to verify lead integrity.Additional information was received that this patient was seen for a follow up appointment with the electrophysiologist.The right atrial lead was turned off due to patients chronic atrial fibrillation.The patient will be monitored through the home monitoring equipment.The device and leads remains implanted.No additional adverse patient effects were reported.

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.Engineering analysis and testing of returned products identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.

Event Description

It was reported that this patient with a implantable cardioverter defibrillator (icd) and non-boston scientific leads was hospitalized in the intensive care unit, due to hemodynamic issues.It is not known if the hemodynamic issues were due to patient condition or related to the device.The hospital does not have a programmer to interrogate the device.The patient reported hearing tones emitting from the device, and right ventricular (rv) lead had high, out of range pacing impedance (greater than 2400 ohms).A technical service (t/s) consultant reviewed device data available from november, reporting that the tones could be related to the high out of range pacing impedance.The patient reported having a mitral clip implanted in (b)(6) 2020.T/s consultant recommended programming options, and recommended having the patient follow up with the primary electrophysiologist for an interrogation of the device, lead integrity testing and x-ray images to verify lead integrity.Additional information was received that this patient was seen for a follow up appointment with the electrophysiologist.The right atrium lead was turned off due to patients chronic atrial fibrillation.The patient will be monitored through the home monitoring equipment.The device and leads remains implanted.No additional adverse patient effects were reported.

• Brand Name: ORIGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11211797
• MDR Text Key: 228164673
• Report Number: 2124215-2021-01199
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534478
• UDI-Public: 00802526534478
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2021
• Device Model Number: G051
• Device Catalogue Number: G051
• Device Lot Number: 132057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other