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

Model Number 7742

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Dizziness (2194)

Event Date 05/28/2015

Event Type  Injury  

Event Description

Boston scientific received information that the patient with this right ventricular (rv) lead presented to the hospital after feeling lightheaded.An interrogation of the pacemaker found that the rv lead was not sensing and there was intermittent capture in both unipolar and bipolar configurations at maximum outputs.The intermittent capture resulted in the patient having an average heart rate at 45 bpm.The pacing impedance measurements remained in normal range at 736 ohms.A chest x-ray was performed and there were not any obvious changes in lead position; a lead microdislodgment was suspected.A lead revision was performed the next day.The lead was able to be repositioned with good measurements; however, the helix would no longer deploy.This rv lead was explanted and successfully replaced.The new lead yielded normal measurements with the currently implanted pacemaker.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was retracted and dried blood was present in the helix housing.A laboratory technician tested the helix mechanism and found it was nonfunctional.Resistance testing found the lead was not electrically continuous, and detailed analysis confirmed that the cathode conductor coil was fractured at the distal end of the terminal pin.Microscopic analysis confirmed that the lead became fractured due to torsional overstress.Laboratory analysis concluded that the rv lead had fractured which caused the clinical observations of intermittent capture and helix issues.

• 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 55112 ; 6515824786
• MDR Report Key: 4884639
• MDR Text Key: 6019665
• Report Number: 2124215-2015-07844
• Device Sequence Number: 1
• Product Code: DTD
• 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
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2017
• Device Model Number: 7742
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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
• Treatment: 7741; L111; 7742
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention