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

Model Number 7842

Device Problems Difficult to Insert (1316); Off-Label Use (1494); Material Integrity Problem (2978)

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

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, a supplemental report will be filed at that time.

Event Description

It was reported that this brady lead was attempted during an implant procedure due to physical damage of the lead on the terminal end.It was noted that the stylet would not go down the lead after slitting the sspc3.A different lead was implanted and remains in service.No additional adverse patient effects were reported.

• 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: 14033531
• MDR Text Key: 288791893
• Report Number: 2124215-2022-04364
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: 00802526604522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2023
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1057774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Male