MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY+; IMPLANTABLE LEAD

Model Number 7842

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.This report will be updated should further pertinent information be provided from the analysis.

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant due to a lead body damage.After multiple attempts to reposition the lead, the physician could no longer advance a stylet down the lumen of the lead.He then requested a new one.No adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated should further pertinent information be provided from the analysis.Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was retracted and dried blood/tissue was present around the helix.Detailed analysis confirmed that the inner conductor coil is intact.The difficult to position allegation was not confirmed.Analysis found no damage or defect consistent with placement difficulty.The difficult to insert allegation was not confirmed.A stylet insertion test passed indicating no blockage in the lumen.The damage/defective allegation was not confirmed.No visible damage to the lead tip, lead body or helix.

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant due to a lead body damage.After multiple attempts to reposition the lead, the physician could no longer advance a stylet down the lumen of the lead.He then requested a new one.No adverse patient effects were reported.

• Brand Name: INGEVITY+
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10708274
• MDR Text Key: 212268937
• Report Number: 2124215-2020-20894
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: 00802526604522
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1015308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1
• Patient Age: 76 YR