MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; IMPLANTABLE DEVICE

Model Number V273

Device Problems Pocket Stimulation (1463); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem Muscle Stimulation (1412)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety core.Review of device history revealed the device exhibited three codes which caused the device to revert to safety core.Due to operating in safety core, the device began to bi-ventricular pace resulting in the patient experiencing phrenic nerve stimulation.Boston scientific technical services (ts) recommended emergent device replacement.Subsequently the device was explanted and successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device could be interrogated but a full download of device memory was not possible.Review of device data identified memory errors.The device case was removed to facilitate inspection of the internal components and further testing.The battery was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short resulted in the memory errors identified in the laboratory setting, in the swollen battery, and in the clinically-observed reversion to safety mode operation.

Event Description

This supplemental report is being filed to include product investigation details.

• Brand Name: INTUA
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9187576
• MDR Text Key: 162337674
• Report Number: 2124215-2019-20802
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2015
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 100181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 02/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR