MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2018

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode indicating that three device faults had occurred.Immediate device replacement was recommended.The crt-p was explanted and returned for analysis.No additional adverse patient effects were reported.

Event Description

This supplemental report is being filed due to the completion of product evaluation.

Manufacturer Narrative

The device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Interrogation of the device verified it was in safety core with brady therapy remaining available.Review of the device memory noted several fault codes had been recorded.Device battery status was beginning of life (bol); however, testing identified a high current drain.The device case was opened to facilitate inspection of the internal components.Detailed analysis identified the sources of the high current drain as a supply filter capacitor and a location of the application-specific integrated circuit (asic).This device detected the issues with these components and issued the clinically observed faults as a result.This device was designed such that if a certain number of faults are detected, the device reverts to safety core to preserve critical function.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8179957
• MDR Text Key: 130870549
• Report Number: 2124215-2018-62382
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 100371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR