MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY+; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES

Model Number 7842

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that this pacemaker system recorded two signal artifact monitor (sam) events.As a result, the minute ventilation (mv) sensor was automatically disabled.Technical services reviewed available device data and noted noise on both the right ventricular (rv) and right atrial (ra) channels.The noise observed was consistent with a signal coming from mv as well as a component of non-cardiac origin.The noise was over-sensed in both the ra and rv channels.The recorded impedances were out of range at the time of the event recording.Additional investigation was recommended to evaluate for a possible lead issue.No adverse patient effects were reported.This rv lead remains in service.

Manufacturer Narrative

This lead remains implanted; therefore, technical analysis cannot be conducted.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this pacemaker system recorded two signal artifact monitor (sam) events.As a result, the minute ventilation (mv) sensor was automatically disabled.Technical services reviewed available device data and noted noise on both the right ventricular (rv) and right atrial (ra) channels.The noise observed was consistent with a signal coming from mv as well as a component of non-cardiac origin.The noise was over-sensed in both the ra and rv channels.The recorded impedances were out of range at the time of the event recording.Additional investigation was recommended to evaluate for a possible lead issue.No adverse patient effects were reported.This rv lead remains in service.To date, no additional information has been received.Should additional follow-up information be provided in the future, an updated report will be issued.

• Brand Name: INGEVITY+
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18924247
• MDR Text Key: 337907448
• Report Number: 2124215-2024-16206
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1251607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1