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

Model Number 7741

Device Problems Product Quality Problem (1506); Ambient Noise Problem (2877); Device Dislodged or Dislocated (2923)

Patient Problem Scar Tissue (2060)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

This ingevity lead was returned to boston scientific¿s post market quality assurance laboratory with the helix mechanism in a retracted position.Subsequent electrical and mechanical testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported helix extension/retraction problems.

Event Description

Boston scientific received information that this right ventricular (rv) lead had dislodged.A revision procedure was performed and due to scar tissue and a difficult initial implant procedure, the decision was made to explant this lead and replace it.During the procedure, noise was observed on both channels due to the device being out of the pocket with open ports.A replacement lead was implanted and interfaced to the device without further incident.No additional adverse patient effects were reported.

• 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: 6024283
• MDR Text Key: 57249255
• Report Number: 2124215-2016-16585
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/09/2016

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: Lay User/Patient
• Device Expiration Date: 05/25/2018
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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: 7740; 7741; 7742; L331
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR