MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY MRI LEADS; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number MODEL 7741

Device Problem Device Inoperable (1663)

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

Event Date 03/06/2018

Event Type  malfunction  

Event Description

Physician noted the icd lead to be malfunctioning.Specifically the screw tip was not working, lead removed from patient body intact and new lead was placed.Malfunctioning lead was set aside for vendor.

• Brand Name: INGEVITY MRI LEADS
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n.; saint paul MN 55112
• MDR Report Key: 7464091
• MDR Text Key: 106609577
• Report Number: 7464091
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MODEL 7741
• Device Lot Number: 918454
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR