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

Model Number 7742

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

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

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

Should the lead be returned analysis will be performed and this investigation will be updated.

Event Description

It was reported that three days post implant this lead had dislodged.A revision took place but it was not possible to extend the helix after the helix was retracted.A new lead was used.This lead was expected to be returned.No adverse patient effects were reported.

• 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: 18564041
• MDR Text Key: 333482449
• Report Number: 2124215-2024-03318
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7742
• Device Catalogue Number: 7742
• Device Lot Number: 1228241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization