MAUDE Adverse Event Report: CPI - DEL CARIBE INGEVITY; IMPLANTABLE LEAD

Model Number 7742

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Perforation of Vessels (2135)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

Following return and completion of laboratory analysis, this event will be further updated.

Event Description

Boston scientific received information that a few days post an uncomplicated right ventricular (rv) lead implant, the patient returned with chest pain and dyspnea.A fluoroscopy image confirmed a rv perforation.The rv lead was later explanted and replaced with a tined end, lead model.The explanted lead is expected to be returned for analysis: no additional medical intervention was required.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection noted a severed lead.The returned segment was 55cm from the terminal end, in length; the tip portion was not received.Setscrew marks on the terminal end were noted and confirmed in the correct location.Testing was completed to assess lead segment's electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections on the terminal end confirmed no fractures.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: INGEVITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7619901
• MDR Text Key: 111687632
• Report Number: 2124215-2018-09760
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2020
• Device Model Number: 7742
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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
• Treatment: 7741; 7742; L311
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR