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

Model Number 7741

Device Problem Human-Device Interface Problem (2949)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/01/2015

Event Type  Death  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that a patient implanted last years with these invegity leads, presented with a tamponade due to perforation.It was later learned the patient passed away.Due to the event having taken place last year, the field representative is unable at this time to provide any other case information.

Event Description

A continuation of investigation has learned the patient involved with this perforation was not deceased, as previously reported.No additional information was received regarding intervention required due to the tamponade post implant.Boston scientific's technical services along with cooperation from the attending implanting physician, conducted a site review so as to provide direct interaction with the ts consultant and physician.The physician reported nothing abnormal during the implant procedure; post implant values all appeared normal.Additionally the physician stated there was nothing remarkable about the handling of the leads during the procedure.X-ray images were then reviewed by both parties, followed by a lead design discussion, focusing on the handling aspects per instructions for use (ifu), specifically regarding the flexible of the lead tip.The physician was displeased with the 6f lead tip design and felt it was contributory to the perforation observed.To date, the lead remain implanted and in service.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5676801
• MDR Text Key: 45830685
• Report Number: 2124215-2016-08482
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 05/26/2016

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: Health Professional
• Device Expiration Date: 03/04/2017
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2015
• 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): Death; Life Threatening