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

Model Number 7736

Device Problems Mechanical Problem (1384); Impedance Problem (2950); High Capture Threshold (3266)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that during the implant it was not possible to extend the lead helix.The pacing thresholds and pacing impedance measurements were also high.The lead was not used and was expected to be returned.No adverse patient effects were reported.

Manufacturer Narrative

This report is being filed to correct the device codes.

Event Description

It was reported that during the implant it was not possible to extend the lead helix.The pacing thresholds and pacing impedance measurements were also high.The lead was not used and was expected to be returned.No adverse patient effects were reported.The product has been received for analysis.

• Brand Name: INGEVITY MRI
• 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: 18953599
• MDR Text Key: 338346002
• Report Number: 2124215-2024-17275
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P150012/S000
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7736
• Device Catalogue Number: 7736
• Device Lot Number: 1091034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female