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); Pacing Problem (1439); No Apparent Adverse Event (3189)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that this lead exhibited a non-specific product performance issue and was not able to be implanted.No adverse patient effects were reported.The lead was expected to be returned for analysis.

Event Description

It was reported that this lead exhibited a non-specific product performance issue and was not able to be implanted.No adverse patient effects were reported.The lead was expected to be returned for analysis.Additional information was later provided.The lead was attempted to be implanted into the right ventricle (rv), but during the procedure, there was no pacing output and the guidewire was unable to progress through the lead.At this time, the attempted lead was not returned for analysis.This report will be updated if the lead is later received.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 16916102
• MDR Text Key: 315062932
• Report Number: 2124215-2023-23503
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1102200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1