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

Model Number 7842

Device Problems Failure to Capture (1081); Mechanical Problem (1384); Off-Label Use (1494); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); High Capture Threshold (3266)

Patient Problem Cardiac Perforation (2513)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this lead implanted in an off-label way at the left bundle branch (lbb) found intermittently capturing at maximum output.An x-ray analysis showed lbb lead may have moved forward.A new lead was implanted in the lbb, nonetheless, after testing of the newly implanted lead, the old lbb lead was attempted to be removed.Over 60 turns of the helix, body turns and manipulation with firm stylet were done but the helix did not retract.X-ray showed the helix stretched into a spike or hook.Doctor decided to abandon lead and plug it into the inactive right atrial lead port.The lead was turned off to allow future magnetic resonance imaging.No additional 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
• 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: 18938759
• MDR Text Key: 338066796
• Report Number: 2124215-2024-16799
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: 00802526604522
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1267677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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 Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male