MAUDE Adverse Event Report: CPI PLANT - ST. PAUL ACUITY; IMPLANTABLE LEAD

Model Number 4674

Device Problems Difficult To Position (1467); Human-Device Interface Problem (2949); Material Integrity Problem (2978)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

This lv is expected to be returned for analysis.This event will be updated upon completion of analysis.

Event Description

Boston scientific received information that during an implant procedure, a guidewire was unable to advance down this left ventricular (lv) lead thus preventing it from being implanted.Later the patient experienced a pericardial effusion and cardiac tamponade due to a perforation which was successfully treated.The cause of the perforation was not determined.The lv lead was never in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, an evaluation of the lead was performed.Inspection of the tip of the lead found no damage or defect.A wire was able to pass through from the terminal to distal tip of the lead without any problems.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5632238
• MDR Text Key: 44425407
• Report Number: 2124215-2016-07398
• 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,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2018
• Device Model Number: 4674
• Other Device ID Number: ACUITY X4 SPIRAL S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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: G158
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR