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

Model Number V173

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem No Code Available (3191)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

This device has not been returned.If it is returned, laboratory analysis will be performed and the report updated upon completion of analysis.Patient code 3191 captures the reportable event of surgery.

Event Description

It was reported that the remote home monitor showed the cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.Boston scientific technical services (ts) discussed that device function was available but limited; explant was recommended.Upon interrogation prior to explant codes were displayed indicating there had been a reset.Subsequently the crt-p was explanted and replaced.No additional adverse patient effects were reported.

Event Description

This report is being filed to submit additional analysis results.

Manufacturer Narrative

Additional review of the information available found that the cause of the safety core was due to an anomaly in the increase in battery impedance.Patient code 3191 captures the reportable event of surgery.

Event Description

This report is being filed to submit the analysis results.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory visual inspection found no anomalies.Review of the device's memory found three resets that caused the device to go into safety core.Interrogation of the cardiac resynchronization therapy pacemaker (crt-p) verified it was in safety core.The device was then reset to primary operation and review found all power supplies to be normal.He device was put through and passed a series of automated tests which verified functionality, sensing and critical therapy availability.The device case was opened and the battery was removed for further analysis.Detailed analysis found no issues with the battery.The underlying cause of the resets and safety core were unable to be determined by laboratory analysis.Patient code 3191 captures the reportable event of surgery.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE PACEMAKER WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9947094
• MDR Text Key: 187179822
• Report Number: 2124215-2020-06682
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Date Manufacturer Received: 11/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR